Medical therapy arrangement for applying an electrical stimulation to a human or animal subject

ABSTRACT

A garment worn by the patient is provided. The garment has a first module electrically connected to a second module. The first module has a first sub-control unit electrically connected to a first electrode and a second electrode placed at a first muscle of the patient and a third electrode and a fourth electrode placed at a second muscle. The sub-control unit is electrically connected to a master unit. The first muscle is stimulated with a first stimulation signal without shortening the first muscle by sending the first stimulation signal to the first electrode placed at the first muscle. The stimulation of the first muscle relaxes the second muscle. A measuring unit (U1) of the master unit determines a first current value flowing from the first electrode through the first muscle to the second electrode and sends the first current value to a central processing unit (CPU). The CPU compares the first current value to a current reference value and increases a voltage of the first stimulation signal when the first current value is below the current reference value.

PRIOR APPLICATIONS

This is a continuation patent application that claims priority from U.S.patent application Ser. No. 16/695,829, filed 26 Nov. 2019 that claimspriority from U.S. patent application Ser. No. 16/680,310, filed on 11Nov. 2019, that claims priority from U.S. patent application Ser. No.16/356,085, filed on 18 Mar. 2019, that claims priority from U.S. patentapplication Ser. No. 14/410,965, filed on 23 Dec. 2014, that claimspriority from PCT patent application no. PCT/SE2013/050700, filed on 17Jun. 2013 that claims priority from U.S. Patent Application No.61/664,282, filed on 26 Jun. 2012 and Swedish Patent Application No.1250685, filed on 26 Jun. 2012.

FIELD OF THE INVENTION

The present invention relates to a medical therapy arrangement.

BACKGROUND OF THE INVENTION

The present invention relates in general to muscle relaxation, and moreparticular to muscle relaxation for spastic muscles in patients havinginjuries to the central nervous system (CNS) at least by using musclestimulation.

Injuries to the central nervous system (CNS) are difficult to treat andcure. Spastic paresis, which is a pathologically increased muscle tonuscaused by an injury to the central nervous system (CNS) is a significantobstacle for prevention of posturing and loss of mobility.

Today, therapeutic alternatives for the reversal of CNS injury symptoms,such as spasticity, are very limited. Therapies are constructed toprevent further loss of function, rather than alleviating the symptoms.No treatment has been found to truly give back function and, in the longrun, reversing the injury through muscle relaxation of spastic muscles.

In addition to the spasms themselves, musculoskeletal pain is a commonrelated complaint. Pain originating from dysfunction in themusculoskeletal system is in most cases caused by muscle spasms due tomuscular imbalance. lithe pain is not treated properly, patients riskdeveloping chronic pain syndromes, conditions that are difficult tocure.

There are several techniques available to affect muscles in the humanbody. Electrical muscle stimulation (EMS), also known as neuromuscularelectrical stimulation or electromyo-stimulation is a commonly knownmethod for increasing muscle mass in specific areas, by providing anelectric current into the muscle causing contraction, which graduallyleads to increased mass in the treated muscle.

Transcutaneous Electrical Nerve Stimulation (TENS) is closely related toEMS, but instead of stimulating muscles to contract, electricstimulation is used to indirectly treat pain, by distracting the brainthrough the stimulation of other body parts. In U.S. Pat. No. 4,580,572,a garment for electrical monitoring of sites or electrical stimulation,such as EMS is disclosed.

However, none of the currently known muscle stimulation techniques issuited to provide for targeted muscle relaxation. Hence, a newarrangement including a garment allowing for increased muscle relaxationwould be advantageous.

In general, the parameters of the EMS current signal may be chosen whichresemble the physiology of the body. The signals in the nervous systemmay be compared to current impulses (stimuli) to the synapses. When acertain amount of stimuli has occurred, signal substances are excreted.

Generally, a phasic EMS-stimulus is given with a frequency rangingbetween 2 and 50 Hz, and having a duration between 5 to 300microseconds.

Muscle relaxation in spastic muscles gives the possibility to inducecontrolled functional muscle contraction in chosen relaxed muscles. Thefrequency needed to induce muscle contraction is higher than thefrequency used for optimal antagonist muscle relaxation (20 Hz/30 μs).Stimulation frequencies for functional muscle contraction are rangingfrom 25 to 50 Hz and the duration needed is between 50-300 μs.

The pulsed EMS current signal is controlled by at least the followingparameters; pulse frequency, pulse duration, pulse strength.

Experiments have shown that muscles start to contract at a pulsefrequency of approximately 15 Hz to approximately 35 Hz, at whichfrequency range the central nervous system feels the presence of thecurrent signal. The present inventor has realized that by choosing afrequency as low as possible, but still detectable by the centralnervous system, the discomfort for the patient is reduced, while theautomatic relaxation of the spastic antagonist muscle is taken care ofby the central nervous system. A higher frequency than approximately 35Hz would lead to shortening of the stimulated agonist muscle andtherefore activation of the stretch reflex in the antagonist musclewhich is not desired, since this would lead to a reciprocal spasm of theagonist muscle.

The pulse duration of the current signal is selected such that itresembles the pulse duration of nervous signals. For example, a pulseduration of approximately 5 to 60 microseconds, such as 30 μs, has beenfound to be suitable. However, even shorter pulse duration could beadvantageous. Too long pulse duration of the EMS current signal does notcorrespond to the neurophysiologic parameters of the body.

Furthermore, longer pulse duration may also increase the risk of muscleshortage, which is not desired.

Since the spastic muscle behavior in CNS injured patients differsgreatly, the professional skills of a neuromuscular system specialistare required for calibrating the system before use, such that thecorrect agonist muscles are provided with EMS electrodes and jointscorresponding thereto are provided with vibrator devices. Every chosenmuscle stimulation is paired with an anatomically relevant jointstimulation in order to strengthen the desired relaxation effect.Furthermore, the parameters of the pulsed EMS current signal need to beselected, which parameters may differ between patients.

The above-described stimulation and calibration techniques are furtherdisclosed in WO-2011/067327, which relates to a system and garment formuscle relaxation of a spastic muscle, and is assigned to the applicantof the present application. In particular the system is adapted to causemuscle relaxation by reducing muscular spasticity through stimulation ofjoints and muscles. The system consists of a garment with electrodes, ahardware unit and software controlling the stimulation.

WO-03/006106 relates to a method and apparatus for electricalstimulation to selected tissues via an array of electrodes positioned onand/or in the body. Each electrode may be connected either as anode,cathode or neither to provide discrimination between stimulated andnon-stimulated regions of tissues of the body.

Today, when performing external electrical stimulation therapy, it iscommon to use electrode patches provided with an adhesive for attachingthe electrodes to the patient's skin. These electrode patches aredisposable, and it is often very time-consuming to attach the electrodesand to connect the electrical cables to each of the electrode patches.

The object of the present invention is to achieve an improvedstimulation therapy arrangement, which is more user-friendly and lesstime-consuming to use, than the presently used adhesive electrodes.

As an electrical stimulation therapy preferably must be applied at least30 minutes in order to give prolonged effect, one further and importantaspect of the stimulation therapy arrangement is that it is comfortableand easy to use for the wearer.

SUMMARY OF THE INVENTION

One great advantage of the arrangement according to the presentinvention is that it is easy to use. This is, among other things,related to that the control unit that includes the pulse generatingcircuitry, is easily attached to the garment by some few manual steps byattaching the connection board to a connection unit which is integratedinto the garment.

The garment is elastic and is intended to be tightly worn by thepatient. The garment is ready for use in a user-friendly way forexternal electrical stimulation therapy of muscles. Electrodes, e.g.silicone-electrodes, are arranged at the inner surface of the garment,the surface facing the patient's skin and in contact to the patient'sskin. The electrical connections connecting the electrodes to connectionunits are flexible and elastic.

The garment is made from materials chosen such that the garment may bewashed in conventional laundry machines.

In particular the garment includes electrical connections adapted toconnect the electrodes to one or several connection units, which do notinfluence the overall flexibility/elasticity of the garment. This isachieved, according to one embodiment, by integrating, e.g. by weavingsilver threads into elastic bands or ribbons or into a piece of elastic.

In another embodiment an insulated conductor is integrated (e.g. weaved)into a piece of elastic.

The connection units are integrated into the garment, they have e.g. aflat extension, and they are flexible. Preferably, they are made from arubber material and are provided with a magnetic material. In particulareach connection element of the connection unit is provided with a magnetbeneath the rubber material and arranged such that a connection pad maybe attached at the upper surface and held in place by the magnet. Theconnection pad is naturally also provided with a magnetic materialenabling the attachment.

The connection pads are arranged at a flexible flat board having themagnetic material arranged at predefined positions in order to exactlyconnect each of the connection pads to a mating connection element ofthe connection unit. The connection board and the connection unit areheld together by the magnetic forces created by the magnetic material atthe respective parts.

According to one embodiment both the connection unit(s) at the garmentand the connection board(s) are made of a flexible material, which is animportant aspect making the garment more comfortable to wear.

According to the invention the control unit is adapted to controlconnection of each of the electrodes to be in the state of acting asanode, cathode, or being disconnected.

By this arrangement it is e.g. possible to stimulate two muscles bythree electrodes if the applied stimulation pulses are separated intime, i.e. one of the electrodes are used for both muscles. Thus, thecontrol unit enables a very flexible control of the application of thestimulation pulses and by using short simulation pulse durations verycomplex stimulation programs may be used in that many muscles and musclegroups may be covered during the therapy.

The control unit preferably applies a so-called open-loop control, i.e.no feedback is used to control the applied current/voltage. Theadvantage of not using feedback is that in case an electrode temporarilyloses contact to the skin, or the contact area between electrode surfaceand skin decreases, the current density of the remaining contact surfacenot should incur pain.

The amount of energy supplied to the patient via the electrodes is muchlower than the energy levels used for by devices for pain relief. Onerisk, or drawback, with such devices is that the applied energy mightstimulate the muscle to contract.

The level of the stimulation energy used in connection with the presentinvention is much lower than used for example in the device described inWO-03/006106.

In the present invention, a garment worn by the patient is provided. Thegarment has a first module electrically connected to a second module.The first module has a first sub-control unit electrically connected toa first electrode and a second electrode placed at a first muscle of thepatient and a third electrode and a fourth electrode placed at a secondmuscle. The sub-control unit is electrically connected to a master unit.The first sub-control unit receives an instruction signal from themaster unit. The first sub-control unit distributes stimulation signalsto the first, second, third and fourth electrodes based on instructionsin the instruction signal. The master unit sends a first stimulationsignal to the first sub-control unit. The first sub-control unitstimulates the first muscle with the first stimulation signal withoutshortening the first muscle by sending the first stimulation signal tothe first electrode placed at the first muscle. The stimulation of thefirst muscle relaxes the second muscle. A measuring unit (U1) of themaster unit determines a first current value flowing from the firstelectrode through the first muscle to the second electrode and sends thefirst current value to a central processing unit (CPU) in the masterunit or the first sub-control unit. The CPU compares the first currentvalue to a current reference value and increases a voltage of the firststimulation signal when the first current value is below the currentreference value.

In an alternative embodiment of the present invention, the CPU of themaster unit or the first sub-control unit measures a voltage signalbetween the third electrode and the fourth electrode mounted on thesecond muscle.

In yet an alternative embodiment of the present invention, the CPU ofthe master unit sends a data unit with instructions to the firstsub-control unit before sending a first stimulation pulse of the firststimulation signal to the first sub-control unit.

In another embodiment of the present invention, the measuring unit U1determines the first current value by continuously measuring a voltagedrop across a resistor R1 prior to a pulse creating switch SW1.

In yet another embodiment of the present invention, the CPU increases avoltage of the first stimulation signal when the first current value isbelow a start current value.

In an alternative embodiment of the present invention, the switch SW1 isopened when the first current value reaches a stop current value and theswitch SW1 is closed when the first current value reaches a startcurrent value that is lower than the stop current value.

In another embodiment of the present invention, a voltage of thestimulation signal is set by allowing the first current value fluctuatebetween the stop current value and the start current value.

In an alternative embodiment of the present invention, a polarity of thefirst electrode and the second electrode is switched.

In yet an alternative embodiment of the present invention, the firstsub-control unit distributes the first stimulation signal to the firstand second electrodes according to the instructions of the data pulse.

In another embodiment of the present invention, the master unit switchesthe first stimulation signal from being in a voltage mode that has aconstant voltage to a current mode that has a substantially constantcurrent wherein the current is only permitted to fluctuate between startcurrent value and the stop current value.

In an alternative embodiment, the CPU changes the frequency and thepulse length of the first stimulation signal.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a schematic block diagram illustrating the medical therapyarrangement according to the present invention;

FIG. 2 is a schematic cross-sectional view of a part of the connectorboard and connector unit according to an embodiment of the presentinvention;

FIG. 3 is a schematic block diagram illustrating another embodiment ofthe medical therapy arrangement according to the present invention;

FIG. 4 is a schematic front view of the body suit or garment accordingto the present invention;

FIG. 5 is a schematic top view of a sub-control unit according to thepresent invention;

FIG. 6 is a cross-sectional side view of the sub-control unit shown inFIG. 5;

FIG. 7 is a schematic view of a stimulation pulse signal at 20 Hz;

FIG. 8 is a schematic view of a stimulation pulse signal at 200 Hz;

FIG. 9 is a schematic view of a sub-control unit connected to an armaccording to the present invention;

FIG. 10 is a schematic view of an arrangement that is switchable betweena voltage mode and a current mode according to the present invention:

FIGS. 11A-B are schematic views of a current signal when the arrangementshown in FIG. 10 is in the current mode according to the presentinvention;

FIGS. 11C-D are schematic views of a current signal when the arrangementshown in FIG. 10 is in the voltage mode according to the presentinvention;

FIG. 12 is a schematic top view of an electrode according to the presentinvention;

FIG. 13 is a schematic cross-sectional view of an electrode shown inFIG. 12 according to the present invention;

FIG. 14 is a schematic view of a stimulation pulse signal that includesdata pulse according to the present invention;

FIG. 15 is a detailed schematic view of a sub-control unit according tothe present invention;

FIG. 16 is a detailed schematic view of a sub-control unit connected toelectrodes according to the present invention;

FIG. 17 is a schematic view of a distribution unit according to thepresent invention;

FIG. 18 is a schematic front view of a portion of the body suit shown inFIG. 4 including sub-control unit mounted on the head of the personwearing the body suit according to the present invention;

FIG. 19 is a schematic view of components of the master unit accordingto the present invention;

FIG. 20 is a schematic view of sub-control unit shown in FIG. 9connected to movement sensors according to the present invention;

FIG. 21 is a schematic view of an alternative embodiment of the bodysuit of the present invention;

FIG. 22A is a schematic illustration of a current in a muscle when thearrangement is in the voltage mode;

FIG. 22B is a schematic illustration of a voltage in a muscle when thearrangement is in the voltage mode;

FIG. 22C is a schematic illustration of 100 Ohm electrodes mounted on amuscle with an internal resistance of 6500 Ohm;

FIG. 22D is a schematic illustration of 1000 Ohm electrodes mounted onthe muscle shown in FIG. 22C;

FIG. 23 is a schematic illustration of a modified sub-control unit ofthe present invention;

FIG. 24 is a schematic illustration of a modified portion of the masterunit of the present invention; and

FIG. 25 is a schematic illustration of an alternative embodiment of bodysuit the present invention that has large electrodes.

DETAILED DESCRIPTION OF PREFERRED EMBODIMENTS

The present invention will now be described with references to theappended drawings.

With references to FIG. 1, the present invention relates to a medicaltherapy arrangement 2, for applying electrical stimulation to a human oranimal subject, comprising a garment 4 adapted to be tightly arranged atsaid subject, and provided with a plurality of electrodes 6 at the innersurface which are adapted to be in electrical contact to the skin of thesubject.

The arrangement further comprises a control unit 8 which is adapted toprovide each electrode 6 to work as one or many of anode, cathode orbeing disconnected, in accordance with a predetermined therapystimulation program.

At least one connection unit 10 is provided which comprises apredetermined number of connection elements 12 being respectivelyelectrically connected to the electrodes 6 via separate connection lines14, which are flexible and elastic. And, at least one connection board16 is provided which comprises a predetermined number of connection pads18 being electrically connected to the control unit 8.

The connection unit 10 is an integrated part of the garment 4 andpreferably arranged such that the connection elements 12 are accessibleto establish electrical connections to the connection pads 18 of saidconnection board 16. In that regard the connection board 16 isdetachably attachable to the connection unit 10 by a fastening means 20,such that the connection unit 10 and the connection board 16, whenattached to each other, are positioned in relation to each other inorder to electrically connect the connection pads 18 to matingconnection elements 12.

According to one embodiment the fastening means 20 is adapted todetachably attach the connection board 16 to the connection unit 10 bymagnetic forces. FIG. 2 is a schematic cross-sectional view of a part ofthe connector board 16 and the connector unit 10. In the figure it isshown that the magnetic forces are created by magnetic material, in thefigure indicated as separate magnets, arranged at predefined positionsof the connection board 16 and the connection unit 10, respectively. Inthe figure the magnets are arranged behind each of the pads 18 andelements 12 in order to secure the electrical connection. As analternative, the magnets may be arranged e.g. behind every second padand element or at positions close to the pads and elements.

The positions of the magnets at the connection board 16 and at theconnection unit 10 ensure that these are correctly positioned inrelation to each other. In order to further improve the positioning, oneor many protuberances and mating indentations (not shown in the figure)may be arranged at the connection board and connection unit,respectively.

As an alternative the fastening means 20 comprises mechanical meanswhich is adapted to detachably attach the connection board to theconnection unit. These mechanical means may e.g. comprise one or manyVelcro straps arranged to provide for the necessary pressure between theconnection board and connection unit in order to establish electricalconnection between the pads and elements. The mechanical means may alsobe embodied by some kind of snap connection.

Preferably, the connection unit 10 has an essentially planar extensionand is made from a flexible material, e.g. a flexible rubber material.

Also, in accordance with one embodiment, the connection board 16 has anessentially planar extension and is made from a flexible material, e.g.a flexible rubber material.

However, it is advantageous that, in particular the connection unit 10,is made from a flexible material, in order to make the garmentcomfortable to wear, but it is also possible, within the scope of thepresent invention, that the connection board 16 and/or the connectionunit 10 is made from a rigid material. According to one embodiment theconnection unit is made from a flexible material but the connectionboard is made from a more rigid material, e.g. from a suitable plasticmaterial.

The connection board 16 and the connection unit 10 have essentially thesame size. In one exemplary embodiment the shape is approximatelyrectangular having a length in the interval of 8-12 cm, a width of 1.5-3cm and a thickness of 0.25-1.5 cm.

Naturally, other sizes and shapes are possible, e.g. circular andelliptical, within the scope of the invention as defined by the appendedclaims.

The connection lines 14, that connect each electrode 6 to a respectiveconnection element 12, are flexible and elastic such the wearer of thegarment may move unimpededly.

According to one embodiment the connection line 14 is included into apiece of elastic into which an electrical conductor is integrated. Thisis achieved e.g. by weaving conducting threads, e.g. made from silver,into the piece of elastic.

As an alternative the connection line 14 is an insulated conductor beingdirectly integrated, e.g. by weaving, into the material of the garment.

The control unit 8 is preferably a separate unit in relation to theconnection board 16, and that the connection pads 18 are connected tothe control unit 8 via an electrical cable 22. According to oneembodiment the control unit 8 comprises a stimulation pulse generator,an energy source, a storage means, an input/output unit and a couplingunit. The energy source, typically being a battery, e.g. a rechargeablebattery, is adapted to energize the circuitry of the control unit, e.g.the stimulation pulse generator. The predetermined therapy stimulationprogram is stored in the storage means and specific instructions relatedto the specific patient to be treated is input by the physician via theinterface. The input/output unit may include one or many buttons and adisplay, e.g. a touchscreen.

The control unit is preferably attached to the garment wearer by somekind of strap in a position where it is easily accessed but not preventsmovements.

In accordance with another embodiment the control unit instead is anintegral part of the connection board, and then the connectingelectrical cable is obviated.

The control unit is preferably adapted to apply an open-loop controlwhen controlling the application of stimulation pulses. I.e. nofeed-back is used which is advantageous in order to avoid that higherstimulation current is applied in the situation where an electrodeloses, or has less, contact to the skin.

The garment is preferably made from a predetermined number ofinterconnectable parts. The reason is that the garment then is easier toput on. Each part is then provided with a connection unit that in turnis connected to the electrodes.

For some patients only a part of the body has to be subjected tostimulation, e.g. an arm or a leg. In that case a garment is used thatis adapted to enclose that part. And, for other patients, the entirebody has to be enclosed by the garment in order to gain full effect ofthe therapy.

An overall requirement of the garment is that it may be tightly arrangedat the body to secure that the electrodes are in contact to the skin ofthe patient. The garment must be able to be washed in a normal laundrymachine. Preferably the garment comprises a synthetic fiber made from apolyurethane-polyurea copolymer, e.g. spandex or elastane.

According to an embodiment, the garment comprises five major textile andsupport materials. Elastic spandex for areas covering muscles and,embedded in this spandex, muscle electrodes for skin contact; firmelastic spandex textile in joint areas to induce joint stability andspecific skin contact of embedded muscle and vibration (if included)electrodes; and Velcro to interlock the garment parts and also inducejoint stability and electrode skin contact. Zippers are placed in thedifferent garment parts to enable simple dressing and use of thegarment. Padding and other supportive materials are placed between thetextile layers to enhance stability and electrode skin contact.

In order to provide for a perfect garment fit for each patient, eachgarment may be tailor made for each patient. Hence, each patient may beindividually measured. Based on the calibration made by the specialist,the therapist chooses which muscles to stimulate and therefore inducemuscle relaxation of corresponding spastic muscles. The tailor-madegarment is produced and the control unit is programmed with thenecessary parameters such as to perform a vibrator (if included) and EMSstimulation in the prescribed manner.

The electrodes are arranged at the inner surface of the garment and musttherefore be flexible to adapt to the skin surface. According to oneembodiment the electrodes are, for example, silicone-electrodes or anyother conductive electrode materials. The number of electrodes isnaturally dependent upon the therapy to be applied, but preferably atleast ten electrodes are included, often much more.

According to another embodiment the control unit comprises a sensingunit adapted to receive electrical signals, e.g. EMG-signals, sensed byone or many of said electrodes. The received signals may then beanalyzed and used to improve the therapy. According to one aspect thesensed electrical signals are used to decide which therapy to be usedand then apply that therapy in accordance with an open-loop controlledstimulation therapy. According to another aspect, it would also bepossible to apply the arrangement in a closed-loop controlled simulationtherapy where the applied stimulation energy is adapted in dependence ofsensed electrical signals.

In a further embodiment the arrangement also provides for combinedelectrical and vibration therapy. This embodiment is schematicallyillustrated in FIG. 3. The same references used in FIGS. 1 and 2 applyhere as well. To use a combined electrical and vibration therapy hasproven an advantageous therapy and in accordance to this embodiment aplurality of vibration units 7 are arranged at the garment, e.g. at theinner surface of the garment, and wherein each vibration unit beingconnected to the connection unit via a flexible and elastic vibrationunit connection line 15. The vibration units may also be arranged at theouter surface of the garment and apply the vibrations through thegarment material.

Different types of vibration units may be used, e.g. based uponpiezo-technology, a so-called DC-motor, or a solenoid-based unit.

Preferably the relation between the number of electrical stimulationelectrodes and vibration units is 2:1. However, even fewer vibrationunits may be used.

FIG. 4 is a schematic view of a frontside of a garment of an elastic andtight body suit 100 of the present invention. The body suit 100 has abackside that is substantially similar to the frontside. The backside ofthe body suit could be designed with wires, electrodes, sub-controlunits in a way that is identical or similar to the frontside. The bodysuit 100 has a plurality of sub-control units integrated into the fabricthat are electrically connected to a plurality of electrodes that arelocated on an inside of the fabric so that the electrodes are facing andurged towards the skin of the person wearing the body suit 100. Thesub-control units make it possible to substantially increase the numberof electrodes in the body suit 100 and to carry out more advancedtreatments of the patient wearing the body suit.

An important feature of the present invention is that the electrodes notonly activate the muscles but also the afferent (sensory) nerves in themuscles that conduct sensory signals from muscle and skin sensors to thespinal cord and act as input to the interneuron networks that areresponsible for controlling the movement of body parts such as an arm ora leg. This happens when the afferent nerves are stimulated at about 20Hz and at a low enough voltage so that the agonist muscle does notcontract to cause movement. Upon receipt of the sensory signals from theafferent nerves, the spinal cord sends a signal to the agonist muscle torelax the muscle. It is important that the frequency range of thestimulation signal can be changed to optimize the afferent input to theinterneuron networks. It is to be understood that any reference to thestimulation of muscles includes the stimulation of nerves in the musclesand other nerves adjacent to the electrodes.

The body suit 100 is used to stimulate and relax muscles and nerves, ofthe person wearing the body suit, with electrical pulses. currentflowing between electrodes mounted in the fabric of the body suit 100and through the muscles on which the electrodes are positioned. When thebody suit has a large number of electrodes but no sub-control units,this creates a problem because all the electrodes must be connected tothe controller or master unit that transmits the pulses and current andother information via wires to the electrodes. The large number of wiresrequired integrated in the suit makes the body suit prone to faultyconnections over time as the body suit is worn by the person and istaken on and off. One solution to this problem is to use sub-controlunits to reduce the number of wires in the body suit and the requiredlengths of the wires going to the electrodes i.e. the wire lengths arealso reduced. The body suit can include modules wherein the sub-controlunits in each module are distributing the stimulation pulses that arrivefrom the master unit.

The sub-control units are controlled by the master unit. Preferably, butnot necessarily, each sub-control unit is electrically connected to themaster unit via only a few wires such as two wires that provide thepower voltage and pulse signals going to the sub-control units. The pairof wires can also carry data instructions to the sub-control units. Itis also possible to send the data instructions by wireless communicationbetween the master unit and the sub-control units.

As described in detail below, one important advantage of using thesub-control units is that a higher frequency and more electrodes can beused in the body suit. In general, the sub-control units receivepulsating stimulation signals from a programmable master control unitthat the sub-control units distribute to pre-determined electrodes tostimulate and/or relax muscles and muscle pairs located below theelectrodes. It is also possible to stimulate nerves similar tostimulating muscles. Muscles are merely used as an illustrative examplebut the stimulation also applies to nerves in the same way. The mastercontrol unit is detachably and electrically connected to the body suitat connectors that are located on an outside of the body suit 100. Themaster control unit also has a power source to power the sub-controlunits located in the modules of the body suit. The modules areelectrically connected to one another via connectors that areelectrically connected to the sub-control units. An important feature isthat the master control unit may be detached from a first connector onthe body suit and re-connected to a second connector on the same bodysuit so that the master control unit or master unit can be moved betweenvarious connectors of the body suit. Each connector has a positive andnegative pole on a first side and a corresponding positive and negativepole on the second opposite side of the connector. The positive pole onthe first side is electrically connected to the positive pole on thesecond side and the negative pole on the first side is electricallyconnected to the negative pole on the second side so that each connectoracts as a “bridge” to carry power, data and pulses from one module tothe adjacent module. A stimulation program runs in the master controlunit, that includes instructions that are sent to the sub-control unitsthrough a serial data bus.

The garment or body suit 100 is preferably made of a flexible andelastic fabric material that tightly fits the body of the patient to betreated. It is to be understood that the body suit 100 is schematicallyshown to illustrate the principles of the present invention and that theexact location of the various components can change or be customized tothe specific needs of the patient to be treated. If the body suit 100should include a large number of electrodes without the use ofsub-control units, this would require large numbers of wires that extendfrom the master unit to all the electrodes. The large number of wiresrequired sometimes makes it unpractical to fit them all in the fabric ofthe body suit and the frequency range must be reduced to lowfrequencies, as explained in detail below. An important feature of thepresent invention is the idea of moving some of the intelligence to thesub-control units that are located in the body suit modules in order toreduce the required wiring and improve the functionality of the bodysuit 100 and to allow higher stimulation frequencies.

More particularly, the body suit 100 may include detachably andindependently functioning modules such as a right arm module 102, anupper body module 104, a left arm module 106, a pelvis module 108, aright leg module 110 and a left leg module 112. The modules arepreferably attached to one another by a suitable fastening mechanism114, 116, 118, 120 such as zippers, Velcro or any other suitablemechanism that can easily be attached and detached. One advantage ofusing modules is that the patient may need different sizes on differentparts of the body. In some instances, the patient may not need all themodules because certain parts of the body are healthy and do not need tobe treated. In general, the paralyzed body portions are smaller in sizethan the non-paralyzed body portions so that different sizes may beneeded. Similarly, a body part, such as an arm, that is spastic isgenerally smaller than a non-spastic body part. The number of electrodesand sub-control units in each module may vary and the body suit 100should merely be treated as an illustrative example.

The right arm module 102 has a first sub-control unit 122 electricallyconnected via a flexible and elastic wire 124 to a negative pole 126 ofa first connector 128 and via a flexible and elastic wire 130 to apositive pole 132 of the first connector 128. One important function offirst connector 128 is to provide a “bridge” from the right arm module102 to the upper body module 104 so that they are electricallyconnected. This function applies to all the other connectors of the bodysuit 100. The connectors may be made of a flexible fabric that includesconductive wires to electrically connect the positive pole on one modulewith the positive pole on the adjacent module and to electricallyconnect the negative pole on one module with the negative pole on theadjacent module. The sub-control unit 122 is electrically connected toelectrodes 134, 136, 138, 140, 142, 144, 146 and 148 via flexible andelastic wires 134 a, 136 a, 138 a, 140 a, 142 a, 144 a, 146 a and 148 a,respectively. The right arm module 102 is electrically connected to allthe other modules of the body suit 100 via the connectors that extendbetween the modules and connect one module to an adjacent module.

The upper front body module 104, preferably, has two sub-control unitsi.e. a second sub-control unit 150 and a third sub-control unit 152. Themodule 104 may have more or fewer sub-control units and the use of twomodules is merely an illustrative example. The sub-control unit 150 iselectrically connected via a flexible and elastic wire 154 to a flexibleand elastic wire 155 that is connected to a positive pole 156 of thefirst connector 128 and via a flexible and elastic wire 160 to aflexible and elastic wire 157 that is electrically connected to anegative pole 162 of the first connector 128. The wire 155 is alsoelectrically connected to a positive pole 194 of a connector 196 that isconnected to the left arm module 106 and the wire 157 is electricallyconnected to a negative pole 200 of the connector 196.

A flexible and elastic wire 175 is electrically connected to wire 155and leads to the backside of the body suit 100 that is identical orsimilar to the front side shown in FIG. 4. Another flexible and elasticwire 177 is electrically connected to wire 157 and extends to thebackside of the body suit 100 so that the wires 175, 177 provide thepower, pulses and possibly data to the backside of the body suit in thesame way as to the front side of the body suit. The sub-control unit 150is electrically connected to electrodes 164, 166, 168, 170, 172, 174,176 and 178 via flexible and elastic wires 164 a, 166 a, 168 a, 170 a,172 a, 174 a, 176 a and 178 a, respectively. The body module 104 iselectrically connected to all the other modules of the body suit 100 viathe connectors that extend between the modules and connect one module toan adjacent module.

Similar to sub-control unit 150, sub-control unit 152 is electricallyconnected via a flexible and elastic wire 192 to wire 155 that iselectrically connected to the positive pole 194 of a second connector196 and via a flexible and elastic wire 198 to wire 157 that iselectrically connected to the negative pole 200 of the third connector196. The sub-control unit 152 is electrically connected to electrodes202, 204, 206, 208, 210, 212, 214 and 216 via flexible and elastic wires202 a, 204 a, 206 a, 208 a, 210 a, 212 a, 214 a and 216 a, respectively.

Similar to the right arm module 102, the left arm module 106 has afourth sub-control unit 228 electrically connected via a flexible andelastic wire 230 to a positive pole 232 of the second connector 196 andvia a flexible and elastic wire 234 to a negative pole 236 of the thirdconnector 196. The sub-control unit 228 is electrically connected toelectrodes 238, 240, 242, 244, 246, 248, 250 and 252 via flexible andelastic wires 238 a, 240 a, 242 a, 244 a, 246 a, 248 a, 250 a and 252 a,respectively.

The pelvis module 108 is located below the upper body module 104 butabove the leg modules 110, 112. The pelvis module 108 is shown withoutsub-control units but the module 108 may also be provided withsub-control units similar to the other modules. The module 108 has anupper connector 184 that electrically connects the pelvis module 108 tothe upper body module 104. The upper connector 184 has a positive pole268 and a negative pole 272 on the pelvis module 108 and a positive pole182 and a negative pole 188 at the bottom end of the body module 104.The positive pole 268 is electrically connected to the positive pole 182and the negative pole 272 is electrically connected to the negative pole188. The positive pole 182 is electrically connected to wire 155 viaflexible and elastic wire 159 and the negative pole 188 is electricallyconnected to wire 157 via flexible and elastic wire 161. The positivepole 268 is electrically connected to the positive pole 276 of a thirdconnector 278 via a flexible and elastic wire 163. The negative pole 272is electrically connected to the negative pole 282 of connector 278 viaa flexible and elastic wire 165. The positive pole 268 is alsoelectrically connected to the positive pole 262 of a fifth connector 286via a flexible and elastic wire 167. The negative pole 272 iselectrically connected to the negative pole 264 of the fifth connector286 via a flexible and elastic wire 169. All the connectors 128, 184,196, 278 and 286 include elastic wiring to electrically connect onemodule with another module.

The right leg module 110 has a fifth sub-control unit 294 electricallyconnected via flexible and elastic wire 296 to a positive pole 298 ofthe fourth connector 278 and via a flexible and elastic wire 300 to anegative pole 302 of the fourth connector 278. The positive pole 298 iselectrically connected to the positive pole 276 and the negative pole302 is electrically connected to the negative pole 282. The sub-controlunit 294 is electrically connected to electrodes 304, 306, 308, 310,312, 314, 316 and 318 via flexible and elastic wires 304 a, 306 a, 308a, 310 a, 312 a, 314 a, 316 a and 318 a, respectively.

The left leg module 112 has a sixth sub-control unit 320 electricallyconnected via a flexible and elastic wire 322 to a positive pole 324 ofthe fifth connector 286 and via a flexible and elastic wire 326 to anegative pole 328 of the fifth connector 286. The sub-control unit 320is electrically connected to electrodes 330, 332, 334, 336, 338, 340,342 and 344 via flexible and elastic wires 330 a, 332 a, 334 a, 336 a,338 a, 340 a, 342 a and 344 a, respectively.

The master unit 266 is connectable to the body suit in many places. FIG.4 shows the positive pole 264 of the master unit 266 electricallyconnected to the wire 155 via flexible and elastic wire 171 and thenegative pole 262 electrically connected to wire 157 via flexible andelastic wire 173. If one of the modules is not necessary such as theright arm module 102, it is possible to connect the master unit 266 tothe first connector 128 or to any of the other connectors. It is animportant feature to be able to connect the master unit at a place thatis convenient to the patient in case the patient has a handicap thatmakes it, for example, difficult to attach the master unit at the hip orif it is more convenient to attach the master unit at the upper shoulderwhen the patient is in a sleeping position. It is also possible to placeseveral connectors in different places in the bodysuit so that themaster unit can be placed there. Preferably, the master unit should beattached to any of the available connectors on the body suit 100. It isthus not necessary to have a separate connection that is only located inone place such as by the hip. It is thus possible to have severaldifferent connection points or connectors for the master unit.

FIG. 5 is a schematic detailed top-view of sub-control unit 122.Preferably, all the sub-control units in the garment or body suit 100are substantially similar to unit 122 serves as an illustrative examplethat applies to all the sub-control units. Preferably, the unit 122 ismolded in a water-resistant material to make it water resistant so thatthe body suit can be machine washed without damaging the electronics inthe unit. The unit 122 may have eight extensions wires that extendoutwardly from the molding i.e. extensions 134 b, 136 b, 138 b, 140 b,142 b, 144 b, 146 b and 148 b that are electrically connected to 134 a,136 a, 138 a, 140 a, 142 a, 144 a, 146 a and 148 a (best shown in FIG.4), respectively. This corresponds to 4 pairs of electrodes persub-control unit. The unit 122 may have more or fewer extensions thaneight. Sub-control unit 122 also has extensions 124 b and 130 b that areelectrically connected to the wires 128 and 130, respectively, thatextend to the connector 128 (best shown in FIG. 4). Power, data andstimulation pulses may enter the sub-control unit 122 via extensions 124b, 130 b from the master unit 266. It is also possible to have moreconnections and send additional information in addition to the power,data and pulse information shown in FIG. 5. Any suitable serialcommunication technology may also be used and more than twowires/connectors can be used that are serially connected. It is to beunderstood that it is possible to combine electrodes in different waysto obtain more than four combinations.

When a frequency of 200 Hz is used for the stimulation signals/pulses,there is a total time period of 5 milliseconds available to send out allthe combinations that the sub-control units handle. If, for example, 8combinations are used then there are 5 milliseconds divided by 8 i.e.625 microseconds between the start of each pulse. If the pulse length is175 microseconds then there are 625 microseconds minus 175microseconds=450 microseconds time gap between the pulses i.e. whenthere is no pulse signal before the next pulse starts. In other words,if, for example, 8 combinations are obtained and the pulse length is 175microseconds and the frequency is 200 Hz then the time gap between thepulses is 450 microseconds. The time gap can be used to do other thingssuch as measuring feedback signals from an antagonistic muscle, asdescribed in detail below in connection with FIG. 9 or to send data asdescribed in FIGS. 14 and 16. It is to be understood that thefrequencies can be increased to a frequency higher than 200 Hz as longas there is a time gap between each pulse.

FIG. 6 is a schematic detailed side view of sub-control unit 122 that isconnected to flexible wires 138 a, 146 a via sewable flexible conductiveconnections or extensions 138 b, 146 b that come out from the moldedsub-control unit, respectively, by overlapping the wires from thegarment to the connectors from the sub-control and then sew themtogether so that they are electrically connected. This principle oranother connection method may be used on all the wires and extensions onall the sub-control units.

As a safety precaution, it is preferred that only the master unit sendsout the stimulation pulses via the sub-control units to prevent thesub-control units from sending out unintended pulses that could be veryuncomfortable or even dangerous to the patient wearing the body suit100. The sub-control units thus merely direct or distribute the pulsesto the correct pair of electrodes. The stimulation pulse, pulse length(duty cycle) and voltage/current etc. are controlled by the (centralprocessing unit) CPU of the master unit by serial data communicationwith all the sub-control units before the pulses are sent out from themaster unit.

As described in more detail below, the sub-control units may haveinformation about the desired pulse length so that the correct pulselength is sent out to the electrodes. The longer the pulse length themore powerful the stimulation is. The pulse length may be set by thetherapist of the body suit or be set by the master unit. In general, thepulses from the master unit have a pulse length that is slightly longerthan the longest pulse length of the stimulation pulse distributed bythe sub-control units. When the pulse length from the master unit islonger than the predetermined pulse out time period then the sub-controlunit can control or reduce the length off the pulse to the electrodes.The master unit also has a safety mechanism for turning off any pulsethat is longer than a predetermined time period as programmed in themaster unit. In the preferred embodiment, these safety mechanisms arenot controlled by the CPU but by circuits in the hardware that areseparate from the CPU and the software for higher safety.

More particularly and as indicated above, two of the connectors 124 band 130 b of all the sub-control units in the suit may be connectablevia electrically conductive flexible and elastic wires to the masterunit for carrying power, data and stimulation pulses. The data in aserial data-bus (between the master unit and the sub-control units) mayinclude instructions to the sub-control units about which electrodesshould be activated and in which order and combination should be used.The arrival of the stimulation pulses from the master unit to thesub-control units indicate when the electrodes, that are connected tothe sub-control unit, should be activated and the sub-control unitsguide or distribute the stimulation pulses to the correct electrodes.The master unit may have a micro-controller (CPU) and the sub-controlunits may each also have a micro-controller (CPU) so that the units cancommunicate with one another. Preferably, the sub-control units shouldbe able to save instructions from master unit and also values from themeasured muscles so that these values can be sent back to the masterunit that also saves the values and so that the master unit can decidewhether the parameters should be changed or not (such asincreasing/decreasing the voltage, current or changing the length of thepulse duty cycle and changing frequency or whether a differentsimulation program should be used. For example, the instructions fromthe master unit to a particular sub-control unit may require that thesub-control unit sends the first pulse to a first pair of electrodes andthe second pulse to a different pair of electrodes etc. It is alsopossible to run a current from an electrode of a first sub-control unitto another electrode of a second sub-control unit.

After a certain number of stimulation pulses have been sent to thesub-control unit, it may be necessary to send different or the sameinstructions to the sub-control unit before additional pulses are sentfrom the master unit to make sure the sub-control units are properlysynchronized and to ensure that the pulses are sent to the correctelectrodes. This synchronization may be done by sending shortsynchronized instructions via the serial data-bus. In some instances, itmay be necessary to turn off the data flow to the sub-control unitbefore the stimulation pulse is sent. It should be understood that thestimulation pulses and data are not transmitted simultaneously when atwo-wired bus is used. The sub-control unit may require to be powered at3V3 volt (3.3V) or 5V. Other voltage levels may be used but the lowerthe voltage of the power the more sensitive the system becomes tointerferences.

The stimulation pulses may be generated by using a voltage ranging from5-100V, more preferably a range of 15-80V is used. Most preferably, 20Vor 40V is used. As explained in detail below, the voltage may beincreased or decreased during the stimulation. As a safety precaution,it is desirable that only the master unit sends out the stimulationpulses and that the sub-control unit should not be able to generate sucha strong pulse signal by itself in case the sub-control unitmalfunctions and sends out a high voltage signal that is too long whichis very uncomfortable to the patient wearing the body suit.Additionally, the master unit may instruct the sub-control units toactivate their outputs in a way so that the outputs send out thestimulation pulses one at a time or a couple pulses at a time. If, forexample, the sub-control units receive instructions from 1 to 5 so thatwhen the first stimulation pulse arrives the sub-control unit 1 sendsout the first pulse to the first electrode pair and when the secondpulse arrives, sub-control unit 2 sends out the second pulse to thesecond electrode pair and so on until when the fifth pulse arrives,sub-control unit 5 sends out the fifth pulse. The process then restartsso that when the sixth pulse arrives to sub-control unit 1, thesub-control unit 1 sends out the first pulse to first electrode pair andwhen the seventh pulse arrives, sub-control unit 2 sends out the secondpulse to second electrode pair and so on until the tenth pulse arrivesand so on. In other words, if one sub-control unit has receivedinstructions to activate 5 pairs of electrodes it starts with the firstelectrode pair again when the sixth pulse arrives to the sub-controlunit. When the master unit re-synchronizes the sub-control units, thesub-control unit can start sending the stimulation pulses to the firstelectrode pair again. For example, if the master unit is connected tofour sub-control unit and each sub-control unit is connected to fourpairs of electrodes then sub-control unit 1 may send out the stimulationpulses when pulses 1 to 4 arrive and sub-control unit 2 sends out thestimulation pulses to its electrodes when pulses 5 to 8 arrive.Sub-control unit 3 sends out the stimulation pulses to its electrodeswhen pulses 9 to 12 arrive and sub-control unit 4 sends out thestimulation pulses to its electrodes when pulses 13 to 16 arrive. Thisprocedure then restarts and repeats the same order with sub-control unit1 to sub-control unit 4 for pulses 17-32 and so on until the master unitchanges the synchronization of the sub-control units. Preferably, allthe sub-control units have a unique address so that the master unit cansend information/data to a specific sub-control unit. It is alsopossible to set all the sub-control units so that they all send out thepulses simultaneously so when pulse 1 arrives all the sub-control unitssimultaneously send this pulse to its electrodes and when pulse 2arrives all the sub-control units simultaneously send out pulse 2 to itselectrodes. If the sub-control units have a different number ofelectrodes connected thereto then the sub-control unit that has thehighest number of electrodes connected thereto determines when pulse 1arrives again over sub-control units that have a lower number ofelectrodes connected thereto. Information about the maximum number ofelectrodes and stimulations for the sub-control unit that is connectedto the highest number of electrodes is sent to all the other sub-controlunits. For example, if one sub-control unit has six differentstimulations to carry out and another sub-control unit only has threestimulations to carry out, the second control unit counts the number ofpulses that have arrived so that when the first three pulses arrive itsends them out at the same time as the first sub-control unit sends outthe first three of the six stimulations. When the second sub-controlunit has sent three stimulation pulses it stops and waits for pulse 7 toarrive to start sending out another three stimulation pulses. The firstsub-control pulse sends out one stimulation pulse for each pulse thatarrives and restarts when pulse 7 arrives so that pulse 7 is sent to thesame electrode pair as pulse 1.

The sub-control units may be designed so that they do not permit astimulation pulse that is longer than a certain threshold value such as200 microseconds or any other suitable pulse length to pass through tothe electrodes. Similarly, the master unit may also be designed so thatit cannot send out stimulation pulses that are longer than anotherthreshold value such as 250 microseconds. If the processor of the mastercontrol unit 266 tries to send out a stimulation pulse that is longerthan the threshold value then the safety circuit of the hardwareterminates the stimulation pulse as a safety precaution. The thresholdvalues can be adjusted so that longer and shorter duty cycles can beused. Preferably, the stimulation pulse from the master control unit 266to the sub-control unit 122 should be slightly longer (such as a fewmicroseconds and up to 30 microseconds) than the maximum pulse lengththat is distributed from the sub-control unit to the electrodes so thatthere is time for the voltage to be received by the CPU of thesub-control unit and to the output circuit to power up the outputcircuit on the sub-control unit before the stimulation pulse isdistributed to the electrodes. The sub-control units may be designed todelay sending the stimulation pulses to the electrodes with, forexample, 10 microseconds to ensure there is sufficient time for thecircuitry on the sub-control units to handle the incoming stimulationpulses from the master unit. It may also be possible to connect thesub-control units to the master unit via blue-tooth, wi-fi, one-wiredata bus or any other suitable wireless or on wire data technology inorder to send data to and from the sub-control units to the master unit.

FIG. 7 is a schematic view 200 of the stimulation pulses 202 that aresent to electrodes in the garment. More particularly, FIG. 7 illustratesan example of when 40 stimulation pulses are sent at 20 Hz and the pulseperiod is 50 milliseconds long in a system that handles all 40electrodes from one unit. As explained in detail below, when a frequencyof 200 Hz is used it is not possible to fit in 40 stimulation pulses(with a duty cycle of 175 microseconds) during the pulse period of 5milliseconds. By using sub-control units, it is possible to increase thefrequency because there are fewer stimulation pulses per sub-controlunit, as shown in FIG. 8. At a frequency of 20 Hz, the time period forone cycle is 50 milliseconds (or 0.05 seconds). FIG. 7 shows 40 pulsesor stimulation combinations wherein each pulse has a duty cycle (pulselength) of about 175 microseconds. Each stimulation pulse activates apair of electrodes. It should be understood that the duty cycle can beshorter or longer than 175 microseconds. After 50 mS at 20 Hz a newfrequency cycle is started. The treatment of a patient wearing the bodysuit 100 may typically last for an hour or so but shorter and longertreatment periods may also be used. Frequency of 20 Hz is suitable tostimulate an agonist muscle in order to relax an antagonist muscle buthigher and lower frequencies of the pulse signal may also be used. Animportant advantage is that after the treatment has stopped, theantagonist muscle remains relaxed for many hours and in some cases fordays.

It is desirable to have the ability to change the frequency range sothat the frequency used can be customized to the required treatment ofthe patient. Preferably, it should be possible to change the frequencyrange between 1 Hz -200 Hz. It should also be possible to vary thevoltage used i.e. to change the amplitude of the pulses. One problem isthat if 40 stimulation pulses are desired at 200 Hz, only a time periodof 5 mS is available (when one frequency cycle at 200 Hz) and if thepulse length is 175 microseconds then the total pulse length for 40pulses is 7 mS (40×175 microseconds) without the time gap between pulseswhich exceeds the time period available (5 mS) for one frequency cycleso it is not possible to run the system at 200 Hz.

FIG. 8 is a schematic view of a stimulation signal 512 with stimulationpulses 494 at a 200 Hz frequency at one frequency cycle 496 of 5 mS sothat there is a time gap 498 between each stimulation pulse 494. Higheror lower frequencies of stimulation signal 512 may also be used and 200Hz is merely an illustrative example. Each stimulation pulse 494 has apulse length or duty cycle 495. This means there is enough time to sendout about 20 stimulation pulses as a maximum of combinations when thefrequency is 200Hz and the pulse length or duty cycle 495 is 175microseconds for each pulse. It is necessary to have a time gap betweenthe outgoing pulses. If 5 milliseconds are divided into 20 pulses, 250microseconds are available for each stimulation pulse and if the pulselength is 175 microseconds then there is a time gap of 75 microsecondsbetween each stimulation pulse. As indicated above, this can be solvedby using sub-control units in each module, as shown in FIG. 4. Whensub-control units are used in the body suit each sub-control unit may,for example, be connected to 8 electrodes. This means that a higherfrequency than 20 Hz may be used and that it is possible to carry outmore than 8 stimulation combinations per sub-control unit. In otherwords, it is not necessary to limit the use to certain pre-set pairs ofelectrodes but use different combinations of electrodes that arestimulated. For example, it may be possible to send stimulating pulsesto electrodes that are located on the same side of an arm but at adistance from one another. It is also possible to send stimulatingpulses to electrodes that are located on opposite sides of the arm suchas one electrode at the front of the arm and another electrode locatedat the backside of the arm. It is also possible to combine thesub-control units so that, for example, a sub-control unit (such as unit150) in the upper body module distributes a stimulation pulse to apositive electrode (such as electrode 174) in that module while anothersub-control unit (such as unit 152) in the upper body module negativelyactivates an electrode (such as electrode 204) in the upper body moduleso that are current goes from the positive electrode of one sub-controlunit to the negative electrode of another sub-control unit

When, for example, four electrodes are used, it is possible to stimulatethe electrodes in more than two ways when each pulse corresponds to oractivates a pair of electrodes. By using sub-control units, theavailable time period available (5 ms) at 200 Hz is enough time tostimulate 8 electrodes because when the duty cycle for each pulse is 175microseconds. It is possible to generate at least 25 different pulses toelectrodes or fewer during this time period which is more thansufficient to stimulate different combinations of 4 pairs of electrodes.In practice, fewer than 25 pulses can be generated because it isimportant to have a time gap between each pulse in case, for example,there may be a need to take measurements on the antagonist musclesbetween the pulses or to communicate with the master unit during thetime gap between the stimulation pulses. It is undesirable to takemeasurements during the duty cycle of a stimulation pulse because thestimulation pulse to a certain muscle and/or nerve (agonist) is likelygoing to interfere with the measurements of the voltage signals atanother adjacent muscle (antagonist).

FIG. 9 is an illustrative example of a patient's arm 509 inside theright arm module 102 of body suit 100. The arm is shown in an extendedsemi-straight position although it is most common for spastic patientsthat the arm is locked in a bent position and the patient finds itdifficult or impossible to stretch out or extend the arm withoutassistance. The electrode 134 may be placed at insertion or first end500 of an agonist muscle and/or nerve 502 while electrode 136 may beplaced at origin or second opposite end 504 of the muscle and/or nerve502 so that current passes from the sub-control unit 122 via stimulationsignal 512 to the electrode 134 via and through the agonist muscleand/or nerve 502 to the electrode 136 and then back via return signal515 to the sub-control unit 122. The direction of the current flow maybe changed so that the current flow goes in the opposite direction, asdescribed in detail below regarding FIG. 15. The electrode 138 may beplaced at insertion or first end 506 of an antagonist muscle 508 and theelectrode 140 may be placed at origin or second end 510 of theantagonist muscle 508. It is also possible to place the electrodes inthe middle of or at another place of the muscle or nerve. It is alsopossible to use separate electrodes to measure signals from the muscleand other signals such as EMG signals.

For example, the agonist muscle and/or nerve 502 may have a function ofmoving the arm 509 in a first direction while the antagonist muscleand/or nerve 508 has the function of moving the arm in a seconddirection that is opposite the first direction. Agonist/antagonist pairsof muscles are needed in the body because muscles can only exert apulling force and cannot push themselves back into their originalposition. For example, the upper arm has biceps and triceps muscles.When the biceps muscles are contracting, the triceps muscles are, in anormally functioning person, relaxed and stretched back to theiroriginal position. The opposite occurs when the triceps musclescontract. The muscle that contracts may be labeled the agonist musclewhile the muscle that is relaxed/stretched may be labeled the antagonistmuscle.

An important insight of the present invention is that a mild stimulationof the agonist muscle leads to slight contraction (increased tension)without shortening of the agonist muscle and a relaxation of theantagonist muscle through reciprocal inhibition. When the antagonistmuscle is spastic, the muscle is abnormally tense. The agonist muscleshould be stimulated without the agonist muscle causing a movement of,for example, the arm. If the agonist muscle is stimulated too much, amovement of the arm is created and the antagonist muscle may respond bybecoming tense again which is undesirable. Too much stimulation of theagonist muscle may be caused by using a frequency that is too high, apulse that is too long or a current/voltage of the stimulation signalthat is too high. When the agonist muscle is merely stimulated togenerate a signal to the central nervous system without causing theagonist muscle to shorten, the reciprocal inhibition causes theantagonist muscle to relax so that it is in a reduced spastic state. Therelaxation of the spastic muscle can sometimes also remove pain in thespastic muscle particularly for patients who do not have a brain damage.The stimulation may also be used to treat pain, tremors, muscleregeneration, induce muscle elaxation, reduce spactisicty, reduce pain,increase muscle tone, facilitate muscle contraction, induce musclecontraction, increase muscle strength/mass, accelerate regeneration ofmuscles/nerves, increase blood flow/circulaton, increase bloodoxygeneation, reduce vein tension, induce relaxation, improve sleep,reduce tremours, reduce bed soars (abitus redution), reduce pathologicalreflexes/central nerve reflexes, treat depession, reduce trauma, use astensin reduction therapy, induce embodyment practice, hyperactivitydisorders, autism spectrum deseases and reduce stress disorders.

Signals are sent from the stimulated agonist muscle to the centralnervous system that, in turn sends a signal to the antagonist muscle toinitiate a relaxation of the antagonist muscle. The relaxation, which isa type of reflex from the central nervous system, is particularlyimportant when the antagonist muscle is a spastic muscle i.e. subject toinvoluntary or abnormal contraction. The nervous system senses thestimulation of the agonist muscle whereby the antagonist muscleexperiences a reciprocal inhibition. The signal from the agonist systemto the central nervous system is thus created in an artificial way byfirst stimulating the agonist muscle with pulses to the electrodes inthe body suit of the present invention. The frequency andvoltage/current level of the stimulation signals to the agonist muscleneeded to induce muscle contraction is higher than the frequency andvoltage/current needed on the agonist muscle to cause a relaxation ofthe antagonist muscle. In other words, the selected frequency andcurrent of the stimulation signal/pulse should be as low as possible toprevent shortening/contraction of the agonist muscle but high enough tobe detected by the central nervous system in order to trigger thereciprocal inhibition. A frequency range of 5-200 Hz may be used, morepreferred a range of 15-100 Hz and most preferred about 20-60 Hz. It isimportant to realize that the antagonist muscle must first be relaxedbefore higher frequencies and current (pulse) levels are used on theagonist muscle to cause it to move. The higher frequencies, currentlevels and pulse length may be used to contract the agonist muscle somuch that it shortens and cause a movement of, for example, an arm. Inother words, the stimulation (pulse) signal can be used to artificiallymake the agonist muscle actively contract without outside physicalassistance by, for example, a therapist. As mentioned above, this typeof stimulation should not be done before the agonist muscle has beentreated with gentle stimulation to cause the antagonist muscle to relax.

It is also possible to measure the brain voltage signals (such aselectroencephalogram (EEG) signals) (see FIG. 18 for details) oractivity of the person wearing the body suit 100 during treatment sothat it is recorded what the brain voltage signals are when the personthinks about moving the arm. This activity can be stored in the masterunit so next time the patient thinks that he/she would like to move thearm, the system of the present invention recognizes the brain activityby comparing the measured signals with the recorded signals andartificially provides the correct stimulation signals to the muscle toactively move, for example, the arm in the way the patient wantedaccording to the brain signals of the person. There may be anotherdifferent brain signal activity when the patient wants to do somethingelse such opening a hand that the system could also recognize and then(after the antagonist muscle has first been relaxed) sends theappropriate stimulation signal to the correct agonist muscle to open thehand. The master unit may first receive the brain signals and thenconvert this information to the correct stimulation signals to thevarious muscles. As best shown in FIG. 9, the master unit 266 sends outthe pulsating stimulation signal 512 via sub-control unit 122 to theelectrode pair 134, 136 to sufficiently stimulate the agonist muscle 502to cause a natural signal (triggered by muscle 508) to be sent from themuscle 508 to the central nervous system without causing the muscle 502to shorten.

The signal 512 includes pulses 494 (as shown in FIG. 8) at a desiredpulse frequency such as any value between 1-200 Hz and with short pulselengths (duty cycle) so that there are time gaps 498 between the pulses494. By using a sensitive measuring device, it is possible to measure avoltage difference between electrodes 138 and 140 placed on theantagonist muscle 508 or separate sensors. In this way, the voltagesignal from electrode 138 is compared to the voltage signal fromelectrode 140. Preferably, this voltage should be measured during thetime gap 498 so that the stimulation pulse 494 does not interfere withthe measurement. The measured voltage is indicated in a feed-back signal547 or 549 signal from the antagonist muscle 508. The feed-back signalsare preferably amplified by an amplifier. More particularly, themeasuring device should be able to measure micro to milli-voltsdifferences between two electrodes that are mounted on the antagonistmuscle 508 that is not used for the stimulation. It is important torealize that just because the natural voltage signals from the musclesare so small, it is necessary that the sub-control unit is close to (nomore than a couple of decimeters) the electrodes. Otherwise, if themeasurement device is far away such at the hip the millivolt signalsfrom the arm muscle disappear into the white noise and/or are interferedwith by other electrical signals in the bodysuit. It is also possible touse separate or different electrodes for these measurements. It is thusimportant that this feedback voltage signal is only measured during thetime gap 498 between the pulses 494 so that the stimulation pulses sentto the agonist muscle 502 are not interfering with the delicatemeasurements at the antagonist muscle 508. It is also possible tosimultaneously treat many parts of the body so that signals aresimultaneously activated from several sub-control units. Of course, itis also possible to stop sending the stimulation pulses during themeasurement of the antagonist muscle when the time to measure betweenthe pulses is too short. The feedback voltage signal between 547 and 549decreases as the antagonist muscle 508 becomes more relaxed as anindirect result of the mild stimulation of the agonist muscle 502. Thefeedback voltage signal can be compared to earlier measured values sothat it is possible to see how the antagonist muscle 508 becomes more orless relaxed. For example, if the voltage value is first measured to,for example, 2 mV and when the voltage value is gradually reduced to,for example, 1 mV, this means the stimulation effect of the agonistmuscle 502 has had a desired effect on the antagonist muscle 508. It isto be understood that it is the naturally occurring voltage caused bythe central nervous system in the antagonist muscle 508 that is measuredbefore, during and after treatment of the agonist muscle 502.

The naturally occurring voltage in the antagonist muscle 508 is verysmall and requires an amplifier to be detected and measured. In thepreferred embodiment, the sub-control unit 122 has a first amplifier 123and a switch control 125 that can be switched between an open or closedposition. FIG. 9 shows the switch control 125 in an open position whichis the position used when the pulse 494 of stimulation signal 512 isbeing transmitted to the muscle 502 to stimulate it. When the switchcontrol 125 is in a closed position, the voltage between electrodes 134,136 may be measured via lines 512, 515, when in between the pulses orwhen the switch is closed and the stimulation signal 512 is stopped.This means the electrodes 134, 136 may be used not only to stimulate themuscle 502 but also to measure the natural voltage in the muscle afterit has been exposed to the stimulation pulses 494. It should beunderstood that muscles 502, 508 are merely illustrative examples andthat all the muscles associated with the sub-control units can bestimulated and measured in the same way. The sub-control unit 122 alsohas a second amplifier 127 and a switch control 129 that can be switchedbetween an open and closed position. In FIG. 9, the switch control 129is shown in a closed position which means that the voltage between theelectrodes 138 and 140 may be continually measured lines 547, 549 oronly measured during the time gap 498 between pulses 494 of signal 512sent to muscle 502 in case the pulses 494 interferes with themeasurement of the voltage in muscle 508. In this way, it can bedetermined how the naturally occurring voltage (caused by signals fromthe central nervous system) between electrodes 138, 140 placed on muscle508 changes as a result of the pulse stimulation of muscle 502. Ingeneral, as the muscle 508 becomes more relaxed the naturally occurringvoltage between the electrodes 138 and 140 decreases. As indicatedabove, it is important to only measure the voltage between electrodes138, 140 during the time gap 498 of the stimulation pulses 494 of signal512 to muscle 502 because if the measurement is done during the dutycycle of one of the pulses 494 then there is a risk that the pulse wouldinterfere with or distort the voltage measurement between electrodes138, 140 mounted on muscle 508. It is also possible to measure thevoltage between electrodes 134, 136 mounted on muscle 502 during thetime gap 498 while muscle 502 is being treated with the stimulationpulses 494. This can be done by switching the switch control 125 to theclosed position during the time gap 498 and then switch it to the openposition before the next pulse 494 is sent to muscle 502. In this way,the changes of the naturally voltage of the muscle 502 that is beingstimulated can also be measured. It is also possible to stop thepulsating stimulation signal while the measurements take place. It is tobe understood that the measurements described above apply to all theelectrodes connected to the sub-control units and combinations ofstimulations via the electrodes connected to the sub-control units.

Instead of using a separate device to measure the feedback signal in theantagonist muscle 508 which means the stimulation signals 512 of theagonist muscle 502 must be stopped during the measurement, it isdesirable to make it possible to measure the antagonist muscle 508during the treatment of the agonist muscle 502 i.e. continuously orduring the time gaps 498 between the stimulation signals 512 that aresent to the agonist muscle 502. The measurement of the muscle 508 mayresult in that the stimulation of the muscle 502 should be changed to adifferent program or the parameters should be modified such as changingthe voltage, current, frequency or pulse length of the stimulationsignal 512. The stimulation of muscle 502 is thus artificially createdby sending the stimulation pulses 494 in signal 512 to the electrode 134while it is the naturally occurring voltage of the antagonist muscle 508(reciprocal inhibition) that is measured and how the current changes inmuscle 508 as a result of the artificial stimulation of agonist muscle502. It is desirable to also save the frequency, amplitude of thecurrent/voltage of the stimulation signal 512 that stimulated agonistmuscle 502 so that the same parameters can be used the next time themuscle 502 needs to be stimulated. As explained in detail below, it maybe necessary to calibrate the signal 512 if it is a voltage mode pulsebecause the natural resistance of the muscle or the contact of theelectrodes with the skin changes over time due to, for example,different humidity or the skin of the patient contains more moisturecompared to the prior measurement or changes in the connections betweenthe electrodes and the skin of the person wearing the bodysuit. However,if it is a current controlled pulse it can be regulated to a fixedcurrent (current mode). For example, it may be necessary to increase thevoltage of the signal 512 to provide the same amount of current runningthrough muscle 502, as described in detail in FIG. 10. This informationmay be saved in the master unit 266 that is connected to the body suit100 so that master unit 266 can ensure that the correct amount ofcurrent flows through the agonist muscle 502 to give the rightstimulation of the agonist muscle. The master unit may also continuouslymeasure the current of the stimulation pulses so it knows in a futurestimulation how much current was required.

The master unit may also calibrate the parameters during the treatmentsuch as increasing or decreasing the voltage or current if, for example,the patient starts perspiring during the treatment which affects theconductivity. This adjustment mechanism makes sure the muscle 502 iscorrectly stimulated even if the external conditions change from onetreatment to another treatment or throughout the course of a treatment.It is also possible to reverse the stimulation to stimulate muscle 508instead. The switch control 129 is then switched to an open positionwhen stimulation pulses are sent to muscle 508 while the switch control125 is switched to a closed position so that the naturally occurringvoltage signal from the muscle 502 can be measured by measuring thevoltage between the electrodes 134, 136 via lines 512, 515 during thetime gap between the stimulation pulses sent to muscle 508.

FIG. 10 is a schematic view of a suitable circuitry arrangement 513 inthe master unit 266 of the present invention wherein the arrangement ischangeable between either a voltage mode or a current mode which makesit possible to automatically control and adjust the current flowingthrough the muscle as a result of the stimulation pulse signal 512. Animportant feature of the arrangement 513 is that it is adaptive andadapts the voltage and other parameters of the stimulation signal 512based on the feedback information regarding the estimated amount ofcurrent flowing through the stimulated agonist muscle 502 as indicatedby the voltage-drop across resistor R1. The estimated current iscalculated from the delta voltage of the voltage-drop divided by theresistance of resistor R1 and the gain from amplifier 767. Thearrangement is thus self-learning or automatic and makes the necessaryadjustments of the stimulation signals based on the feedback in thepulse current value signal 752 that is an input to the master CPU. Inother words, the arrangement 513 may be used to continuously determineor estimate the amount of current flowing through the agonist muscle 502as a result of the stimulation signal 512 in FIG. 9. It is thus possibleto exactly provide and measure the current needed in, for example, theagonist muscle 502 to effectively relax the antagonist muscle 508. Thefeedback signal 752 to the master unit may also used to detect aninsufficient or lack of contact between body and electrodes. If there isno contact between the body and the electrodes the measured current iszero.

FIG. 11A shows a stimulation current pulse 531 as the current ismeasured and regulated by arrangement 513 when the current goes throughthe muscle that is stimulated and FIG. 11B shows a stimulation pulse 519as the delta voltage is measured across resistor R1 as the stimulationpulse leaves switch SW1 to the sub-control unit and electrodes with thecurrent control activated (i.e. when the arrangement 513 is in thecurrent mode). It should be noted that the y-axis in FIGS. 11A-B isexpressed in ampere (A) and the x-axis is expressed in time. Theresulting current of pulse 531 that moves through the muscle issubstantially constant with a low ripple as the current level moves oroscillates between a narrow band of a maximum value and a minimum value.This control of the current level is an important feature of the presentinvention. The actual current of the stimulation pulse is determined bythe low ripple current as set by the current limiter signal from the CPUof the master unit 266. An important insight of the present invention isthat in order to accomplish a substantially constant current it isnecessary to control the current by adjusting the voltage level untilthe right current level is achieved. This is automatically done by thearrangement 513 shown in FIG. 10. Another important feature of using asubstantially constant current (with low ripple) is that when there is apoor contact between the electrodes and the skin, the constant currentcircuit arrangement 513 automatically increases the pulse voltage untila sufficient amount of current is passing through the muscle assumingthat a pre-set voltage maximum is not exceeded for safety reasons.However, when the voltage is constant (as in the voltage mode) thisautomatic adjustment feature is not possible.

FIG. 11D shows a voltage stimulation pulse 520 (wherein the voltage isconstant) as the pulse leaves the switch SW1 to the sub-control unit andelectrodes without the current control activated (i.e. when thearrangement 513 is in the voltage mode). FIG. 11C shows the resultingcurrent when measured as it moves through the muscle. It should be notedthat the y-axis in FIG. 11C is expressed in ampere (A) over time(x-axis) while the y-axis in FIG. 11D is expressed in volt (V) over time(x-axis). The muscles first acts as a capacitor and then as a resistorso that the flank of the voltage pulse results in a high current peak521 while charging the muscle (capacitance) between the electrodesduring the flank of the pulse and the muscle resistance then sets theend current level 525 after the charging is done. In this way, thecurrent is very high in the beginning of the treatment of the muscle andthis can be very uncomfortable to the patient wearing the bodysuit 100.One important advantage of using the current mode (see FIGS. 11A and11B) is that it prevents the initial peak of the current because thecurrent only fluctuates between current start 516 and current stop 518.However, as the electrode age an internal resistance builds up so thatthe current changes according to curve 523 that does not have a highpeak in the beginning. It should also be noted that due to the internalresistance of the electrode, the current in the muscle in curve 523reaches a maximum ampere that is lower than the current level 525 thatis reached when the electrode is new (very little internal resistance)so it may be necessary, when it is in the voltage mode, to raise thevoltage in pulse power 511 to compensate for the internal resistance inthe electrode and so that the maximum in curve 523 reaches the currentlevel 525.

The outgoing stimulation pulse 512, whether in the current mode or inthe voltage mode, is sent from the arrangement 513 of the master unit266 via output from switch SW1 to the sub control units and the CPU ofeach sub-control unit senses the incoming pulse and the pulse alsopowers up the output unit 535 (see FIG. 15) of the sub-control unitssuch as sub-control unit 122. It has been realized that when electrodesage over time their resistance often increases which results in anincreased voltage drop at the electrodes and this results in lessvoltage across the muscle and the current through the muscle drops. Thismeans that the current through the muscle has tendency to decreasealthough the voltage input to the electrodes of the stimulation pulsesremains the same when in the voltage mode. Another factor is that theinternal resistance of the muscles that are treated/stimulated may buildup over time which, in turn, reduces the current that flows through themuscles when the voltage is constant (i.e. when in the voltage mode).

A CPU of the master unit 266, that is electrically connected to thearrangement 513 (in FIG. 10), determines whether the arrangement 513should be in the current mode or the voltage mode according to the setsignal 750 sent from the CPU of the master unit to the arrangement 513.The set signal 750 is either in “0” mode that may represent voltage modeso that the outgoing pulse looks like pulse 520 in FIG. 11D or in “1”mode that may represent the current mode so that the outgoing pulsecurrent looks like pulse 519 in FIG. 11B. The “1” mode may be at anysuitable voltage such as 3.3V, 5V or any other desired voltage level aslong as it is substantially lower than the voltage of pulse power 511.When the arrangement 513 is in voltage mode, the CPU of the master unitsets the voltage 511 to the desired level. When the arrangement is inthe current mode, the CPU of the master units, preferably, sets thevoltage in pulse power 511 to a maximum allowable value (such as 40V).This is possible to do because the arrangement 513 self-regulates thecurrent and provides the required high voltage level to maintainconstant current. Circuitry U1 measures the voltage over resistor R1 inboth cases, i.e. whether the arrangement 513 is in current mode andvoltage mode, but cannot control the current when the arrangement 513 isin the voltage mode. The CPU of the master unit is preferably programmedto the desired mode by software in a computing device such as a personalcomputer, pad or telephone. The stimulation parameters are installed inthe master unit from a regular computer, pad or telephone thatcommunicates with the master unit 266 via wired or wirelesscommunication. One advantage of using the current mode is that if theinternal resistance of the muscle has increased or there is not a goodcontact between the skin and the electrode then the circuit 513increases the voltage of the stimulation signal or pulse power until thedesired current flow between the two electrodes is obtained. Preferablyand for safety reasons, there is a maximum limit of how much the voltagein pulse power 511 can be set to. If the arrangement is in the voltagemode, i.e. the voltage of the stimulation pulse is constant at, forexample, 20V, and when the resistance in the muscle increases or theelectrodes wear-out over time then the current flow in the muscle dropsand in some instances the current may stop flowing.

More particularly, a power unit of the master unit 266, shown in detailin FIG. 19, sends an activation pulse 754 (see FIG. 10) via resistor R2to input on switch controller 760 of switch SW1. The activation pulse754 can either be in “1” mode to close switch SW1 so that the pulsepower voltage 511 can pass through switch SW1 that creates thestimulation pulse signal 512 that continues to the sub-control units.The activation pulse 754 can put the switch SW1 in “0” mode which opensswitch SW1 so that no pulse power voltage 511 can pass through switchSW1. Preferably, the activation pulse 754 is at a voltage level (forexample 3.3V or 5V) that is substantially lower than the voltage levelof the pulse power voltage 511 (for example 20-40V). Signal oractivation pulse 754 thus opens and closes switch SW1 at the desiredpulse interval and pulse length as determined by the CPU of the masterunit so that it is the pulse 754 that sets the frequency of thepulsation of the stimulation signal 512. The CPU in the master unit 266determines the pulse length by sending the activation pulse to switchSW1. The activation pulse signal 754 creates the pulsation of thestimulation signal 512 that leaves the switch SW1 as a pulse at forexample 20V. The time period the activation pulse is in “1” mode is thepulse length or duty cycle of the pulses of the outgoing stimulationsignal 512. The stimulation pulse signal 512 then goes to thesub-control unit that forwards or distributes the incoming stimulationpulse to the correct electrode or electrodes and sends out the correctpulse length that was earlier sent to the sub-control unit by the masterunit. The voltage level or amplitude of the voltage pulses 494 instimulation pulse signal 512, when in the voltage mode, may thus be setby the CPU of the master unit and can vary between, for example,10-100V. Voltage levels of 20V or 40V are commonly used but can thus bevaried. When an “1” signal of control or activation signal 754 is sentthen the switch SW1 closes so that the voltage of pulse power voltage511 can pass through switch SW1 and the outgoing pulse length ofstimulation signal 512 is controlled by the time length the signal 754is in “1” mode before switching to the “0” mode to open switch SW1. Whenthe switch SW1 is open, the delta voltage across resistor R1 is 0 i.e.no current flows therethrough. The activation signal 754 comes from theCPU of the master unit so that the outgoing voltage stimulation signal512 from arrangement 513 at output 537 looks like pulse 520 and thepulse length of the stimulation signal is determined by the activationpulse 754 because when the activation pulse opens switch SW1, i.e.switches to “0” mode, the pulse power 511 can no longer pass throughswitch SW1 and this creates the time gap 498 between the pulses 494, asshown in FIG. 9. In other words, as long as the activation pulse 754 isin the “1” mode, such as for 175 microseconds or any other pulse length,to keep the switch SW1 closed, a stimulation pulse can flow throughswitch SW1 and on to the sub-control units and the electrodes. In thisway, the activation pulse 754 creates one pulse length of thestimulation signal until it switches to “0” mode again to open theswitch SW1 that starts the time gap 498. All sub-control units in thebody suit receives the pulses 494 and each sub-control unit decides ifit should send out the pulse or not to the electrode based on itsinstructions sent to the sub-control units from the master unit 266.

When pulse power voltage 511 passes through resistor R1 and a voltagedrop is formed over the low value resistor R1 (if current flows), thisvoltage drop is continuously measured by circuitry U1 to determine theamount of current of pulse power voltage 511 that passes throughresistor R1. Circuitry U1 measures the voltage difference (for eachstimulation pulse that passes through switch SW1) from the voltage atthe positive pole 761 i.e. prior to resistor R1 which is the voltage ofthe incoming pulse power voltage 511 to the voltage at the negative pole763 after the resistor R1. When the current starts flowing through theR1 and through muscle which results in the voltage drop signal atresistor R1 that circuitry U1 reads and sends out in the signal at 765and feedback signal 752. The information about the voltage difference ispreferably amplified by circuitry U1 and sent in the pulse current valueas a voltage signal 752 to the CPU of the master unit. The CPU or a A/Dconverter converts the current value voltage signal 752 to a digitalvalue for the CPU. Because the resistor R1 has a very low Ohm value, thevoltage drop is in the order of milli-volts. The resistor R1 should beof a very low resistance to minimize the voltage loss as the pulse power511 passes through resistor R1 and onward to the switch SW1 and out as astimulation pulse. Preferably, the signals 765 and 752 are amplified byan amplifier 767 so that the signals 765 and 752 are measurable orreadable by the CPU of the master unit. By knowing the resistance ofresistor R1 and the amplification at circuitry U1, it is possible todetermine the current. Preferably, resistor R1 should have a lowresistance such as 0.1 to 10 Ohm to minimize the losses of voltage inthe pulse signal 512. The information in the feedback signal 752 isimportant because it informs the CPU of the master unit 266 when, forexample, there is insufficient current which may be the result of a poorcontact between the electrodes and the skin so that insufficient or nocurrent is flowing between the electrodes mounted on the stimulatedmuscle and through the muscle.

When feedback signal 752 indicates to the CPU of the master unit 266that the current is decreasing as determined by the voltage drop acrossresistor R1, it could be used by the CPU as a trigger to switch from thevoltage mode to the current mode by changing the signal 750 from a “0”mode to “1” mode to close or activate switch SW2 or to increase thevoltage at 511 in voltage mode to increase the current. It should benoted that the change of the voltage in the voltage mode cannot be donefor each pulse. Instead, it has to be over time and it is the value ofthe average current read value of 752 that decides if the voltage shouldbe raised or not. It is also possible to increase the voltage of thepulse power signal 511 while in the voltage mode to increase the currentflowing through the muscle if it turns out that, for example, theresistance in the muscle has increased. However, it is not possible forthe circuitry U1 to control the current flow for each pulse when thearrangement is in the voltage mode. As explained above, often themuscles behave like capacitors in series with the muscle and electroderesistance so that the current rapidly increases in the beginning of thepulse and then rapidly declines wherein the resistance in the musclesets a lower limit of the current flow during the duty cycle of thestimulation pulse.

The pulse current value signal 752 could be used by the CPU of themaster unit as a feedback signal to determine whether a previousincrease of the voltage in pulse power voltage 511 had any effect on thecurrent flowing through the stimulated muscle, as measured by thevoltage drop across the resistor R1. The aging of the electrodes createsa problem in that the internal resistance in the electrodes can increaseover time. Another problem of using the voltage mode is that theresistance in the muscle is not linear so it is difficult to control andto make sure there is sufficient current flowing through the muscle whenin the voltage mode. An average value of feedback signal 752 may thusprovide information to the CPU of the master unit 266 about the need toincrease the voltage of the pulse voltage 511 to make sure sufficientcurrent is flowing between the electrodes. It is to be understood thatthe CPU may increase the voltage of the pulse power voltage 511 whetherthe arrangement 513 is in voltage mode or current mode. The “1” mode ofactivation signal 754 may be at any suitable voltage such as 3.3V, 5V orany other desired voltage level.

Switch SW1 is a switch that connects the pulse power voltage 511 to thesub-control units that then forward the stimulation pulse signals 512 tothe selected pair of electrodes. As indicated above, the resistance ofresistor R1 is so low that it does not really affect the voltage of theoutgoing pulse signal 512. The control or activation pulse 754 thusrepeatedly opens and closes switch SW1 to disallow or allow,respectively, the pulse power 511 to pass through the switch SW1 asstimulation pulse signal 512 and circuitry U1 continuously measures thevoltage drop across low value resistor R1 that the current causes atresistor R1 to indirectly determine the amount of current flowingthrough the muscles that are treated.

It should be noted that circuitry U1 measures the current (i.e. voltagedrop across the resistor R1 caused by current through resistor R1)regardless whether the arrangement 513 is in current mode or in voltagemode. When switch SW2 is open (“0” mode), i.e. the arrangement is in thevoltage mode, then the circuitry U1 can merely measure the voltage dropover resistor R1 but cannot effectively control the outgoing current inthe outgoing stimulation pulse signal 512 that leaves at output 537 andgoes to the sub-control unit 122. The incoming activation pulse 754 fromthe CPU of the master unit is a low-level pulse that enables (when in“1” mode) the high voltage pulse power 511 to pass through switch SW1 byclosing the switch SW1 to create the outgoing stimulation pulse signal512 at output 537. The pulse power 511 may have any suitable voltage,such as 10-40V, as controlled by the CPU of the master unit.

When switch SW2 is closed (“1” mode), as set by the digital mode (“0” or“1”) of the incoming set signal 750 from the CPU of the master unit 266,then circuitry U1 can affect the outgoing current of the stimulationsignal 512. The circuitry U1 can temporarily open switch SW1 byconnecting the SW1 control pin to GND during the activation signal 754when the current, as determined by the measured voltage drop overresistor R1, has increased to an upper threshold value (stop current) incircuitry U1. When circuitry U1 detects that the voltage drop acrossresistor R1 has increased so that corresponding current has reached theupper threshold value, i.e. the stop current value (as set by thecurrent limit pin on circuitry U1 759) then circuitry U1 connects theSW1 control pin to GND to stop the activation pulse 754 so that switchSW1 opens. When the switch SW1 is temporarily opened by circuitry U1then the delta voltage across resistor R1 declines until a current start516 value is reached when the circuitry U1 releases SW1 control pin fromGND so that pulse 754 closes switch SW1 again by allowing pulse 754 toclose switch SW1. More particularly, when the circuitry U1 senses thatthe voltage-drop (delta V) has declined so that start current 516 valuehas been reached then circuitry U1 releases the SW1 control pin andswitch SW1 closes again so that the pulse power voltage 511 can continueto pass through the switch SW1 and the delta voltage across the resistorR1 starts increasing because the current starts flowing through themuscle again. The current of the activation pulse 754 to SW1 control pinis limited by resistor R2 when circuitry U1 connects signal 754 afterresistor R2 to GND. When the circuitry U1 detects that the voltage-dropacross resistor R1 is such that the current start 516 has been reached,then circuitry U1 releases the SW1 control pin and switch SW1 closesagain and the voltage of the pulse is connected to the electrodes andthe current can start flowing through the muscles and electrodes and thecurrent increases until stop current 518 when the comparator 756 withintegrated hysteresis stops the activation signal 754 again so thatswitch SW1 opens. In this way, circuitry U1 controls the current flow inthe stimulated muscle during the pulse duty cycle of stimulation pulse512 when switch SW2 is closed or active. It is to be understood that thefluctuation of the current between start current and stop current is sorapid that there is not enough time for the CPU to be involved. This iswhy the comparator 756 is used. The voltage to switch SW1 is generatedvia resistor R1 and the activation pulses 754 to switch SW1 that aresent by the CPU of the master unit 266 and the switch SW1 is activatedor de-activated by the activation/control signal 754. When theactivation/control signal 754 is temporarily stopped by circuitry U1 andwhen switch SW2 is in the current mode this in turn opens the switch SW1so that no pulse power current 511 can flow through switch SW1. When theCPU of the master unit 266 sends out a pulse activation command (i.e.“1” command) in the control signal 754 via resistor R2 then the switchSW1 closes and the pulse power voltage 511 can pass through switch SW1.When the sub-control unit 122 then sends the pulse to a selectedelectrode pair and muscle, the current flow starts and this creates thevoltage drop over resistor R1. This voltage drop across resistor R1 iscontinuously measured by circuitry U1 that converts it to the feedbacksignal that is sent to the CPU of the master unit as the pulse currentvalue signal 752. The CPU in the master unit 266 reads the voltage dropinformation in signal 752 as a value of the current of the outgoingpulses of stimulation signal 512. When the CPU of the master unit hasselected the current mode (i.e. set signal 750 is in the “1” mode) thenthe switch SW2 is activated or closed. The corresponding current (asmeasured by the voltage across resistor R1) that is measured bycircuitry U1 is compared to the upper threshold value or current limitof the current as set by the CPU of the master unit. When the currenthas reached the upper threshold voltage value (stop current 518 in FIG.11B) then the transistor or switch 762 connects the SW1 control pin toGND to short-circuit the control/activation signal 754 after resistor R2(wherein resistor R2 is a current limiter) as determined by the currentlimiter comparator 756 in circuitry U1. This assumes that the voltage ofthe pulse power 511 is high enough, considering the total resistance inthe system, so that the current would increase to a value higher thanstop current 518. When the current reaches the upper threshold, thecurrent limiter comparator 756 short-circuits the signal 754 afterresistor R2 so that switch SW1 opens and the current flow stops and thecurrent starts decreasing. When the current has decreased to the startcurrent 516 (as shown in FIG. 11B), the switch 762 disconnects the SW1control pin from ground GND so that pulse power 511 can pass switch SW1and the current can start flowing again. The pulse signal 754 is in “1”mode (at 3.3-5V) before resistor R2 but in “0” mode (i.e. the voltage is0) after resistor R2 when switch 762 is closed and leads pulse signal754 to ground 758. Resistor R2 protects the CPU when there is ashort-circuit to ground because it limits the amount of current that canflow therethrough. The resistor R2 could be in a range of 5-15 Ohm andmore preferred about 10 Ohm. The switch controller 760 senses the changeof pulse signal 754 to “0” mode and opens the switch SW1. The closingand opening of the switch/transistor 762 are controlled by the currentlimit comparator 756. The comparator 756 has a current limit inlet 757that is controlled by the CPU of the master unit so that the CPU can setthe value of the current by sending a voltage value 759. The differencebetween start current 516 and stop current 518 is preferably constantand the signal 759 sets the level or limit of, for example, thestop-current 518 which means it indirectly also sets the limit for startcurrent 516 since the difference (delta) between the start current andstop current preferably remains the same and is determined by thehysteresis of comparator 756. Preferably, the voltage difference shouldtypically be about 20 mV but can be set to another value also. In thisway, the signal 759 can increase or decrease the average voltage value(which is equivalent to an average current value) that is sent to theCPU of the master unit 266 in signal 752. The comparator 756 comparesthe value of the amplified voltage drop signal 765 with the currentlimits of the voltage value 759 and when the voltage drop signal 765 hasreached the current limit (stop current 518 in FIG. 11B) then thecomparator 756 closes the switch/transistor 762 so that the activationpulse 754 goes to ground 758 and the switch SW1 opens. This stops thecurrent through the resistor R1 and the current of the stimulationsignal 512 decreases and when the delta voltage has decreased to a levelthat is equivalent to start current 516 (see FIG. 11B) then thecomparator 756 opens the switch 762 so that switch SW1 closes again andthe current of the stimulation signal starts increasing as shown by theincrease of the voltage drop signal 765 from circuitry U1. The switch762 is kept open until the current, as indicated by the delta voltageacross resistor R1, has increased to the stop current value and theswitch 762 is closed again by comparator 756. The comparator 756 mayhave pre-set hysteresis values so that the comparator has an upper leveland a lower level that it compares the current value against.Preferably, the comparator has one built-in hysteresis value thatcorresponds to the current start value 516 (and current stop value 518)and the CPU of the master unit sets the value for stop current 518. Theopening and closing of switch 762 are extremely quick (such asnanoseconds) and occurs during the duty cycle of the pulse 494 so thatthe switch 762 is opened and closed many times during the pulse. It isimportant that the voltage of the pulse power 512 is sufficiently highso that the current can increase from the start current 516 to stopcurrent 518 when the arrangement is in the current mode. The amount ofcurrent is determined by the resistance in the muscle, electrodes andwiring.

The current thus fluctuates between the upper stop current 518 and lowerthreshold (start current 516) values, as shown in pulse 519 in FIG. 11B.The opening and closing of switch SW1 occur during the duty cycle ofstimulation pulse 494 so the time frame is very short i.e. nanoseconds.It should be noted that the size of the current that flows through themuscle, i.e. between the electrode pairs mounted on the muscle, ispartially decided by the natural resistance in the muscle and whichcurrent that is selected by the signal 759.

It may also be possible to apply the principles of the present inventionto, for example, a hand or wrist that is stiff relative to the lower armso that the hand is fixed in a downward position and the patient isunable to rotate the hand in an upward direction. Today, the hand mustbe forcibly moved in the upward direction. This is very unpleasant tothe patient. An important feature of the present invention is to firstsend stimulation signals to the agonist muscle located on the upper sideof the lower arm to indirectly relax the tense antagonist muscle locatedon the lower side of the lower arm. The amount of relaxation of theantagonist muscle may be determined by measuring the amount ofvoltage-out (EMG) in the antagonist muscle and how this has changed whenit is connected to an electrode pair. After the antagonist muscle hasbeen relaxed for a certain time period so that there is less resistanceof the muscle to be extended, a relatively high voltage or currentsignal is sent to the agonist muscle located on the upper side of thelower arm so that the agonist muscle shortens enough to causemovement/contraction of the agonist muscle (while the relaxed antagonistmuscle extends) to lift the hand at the wrist in the upward directionrelative to the lower arm without using an external mechanical force.This stimulation signal may have a higher voltage, a higherpredetermined current or a longer pulse length (duty cycle) than theparameters used to merely stimulate the agonist muscle (in order torelax the antagonist muscle) so that the stimulation signal contractsthe stimulated muscle in order to move the arm.

FIG. 12 is a top view of an electrode 400 of the present invention whileFIG. 13 is a cross-sectional side view of the electrode. Preferably, theelectrode 400 includes a conductive rubber material that is covered by aconductive layer of gold, silver or any other conductive material. Theelectrode should have no sharp edges. The electrode may, for example, bemade of a conductive woven fiber or silver tread, gold thread, copperwires, stainless steel surgical wires and silicon wires.

The electrode 400 is an illustrative example of an electrode and couldbe one of the electrodes 134, 136 etc. shown in the body suit 100 inFIG. 4. The electrode 400 has a protruding mid-section 402 that is madeof a thin electrically conductive rubber, with metal plating such asgold or any other suitable conductive material. The mid-section 402 maycontain a soft filling material and/or be hollow so that it isinflatable and deflatable. Preferably, the fabric 404 of the body suit100 extends over the outer edge 406 of the mid-section 402 so that thefabric overlaps an outer portion 408 of the mid-section 402. The fabric404 is attached to the outer portion 408 in a suitable way such as usingan adhesive. One advantage of using a conductive metal plating is thatit slides better on the skin of the patient wearing the body suit 100.Conventional electrodes made of a rubber material has a high frictionagainst the skin that makes it harder to take on and off the body suit.A low friction coefficient of the mid-section 402 is important when thebody suit is put on and taken off the patient so that the electrodesslide on the skin. A backside of the electrode 400 may have anelectrically conductive layer of a rubber material. Preferably, thefabric 404 outside the outer portion 408 is sewn to the body suit. Themid-section 402 has an electrically conductive connector 410 thatextends outwardly beyond the outer portion 408. The connector 410 mayoverlap a flexible conductive wire 412 that is connected to one of thesub-control units. An outer portion 414 of the connector 410 may beattached to an outer portion 416 of the wire 412 such as by sewing themtogether. The mid-section 402 may be filled with a soft spongy material418 so that the mid-section 402 protrudes away from the fabric 420 ofthe body suit 100 so that it is urged against the skin 422 of thepatient wearing the body suit 100 to improve the contact between theskin and the electrode. The electrode 400 may also include a tubularportion 424 that extends through the fabric 404. The tubular portion 424may be connected to a balloon-shaped pump 426 that may be used toinflate the inside 401 of electrode 400 so that it expands and protrudesmore to further improve the electrical contact between the metalmid-section 402 and the skin 422. An important feature is that thetubular portion 424 and/or the balloon-shaped pump 426 may be removablyattached so that they may be removed and connected to another electrodethat needs to be expanded by pumping it up. It is also possible toprovide the electrodes with a valve to release the pressure/air when themid-section 402 becomes too hard and the valve automatically closes whenthe pump 426 is removed. The rear-part of the fabric 404 is sewable sothat the electrodes can be sewed to the fabric of the body suit 100.Preferably, only the mid-section 402 is pumped but not the connector410. The electrodes can also be woven into the elastic bodysuit whereinthe electrodes are woven with conductive threads. The conductors to thesub-control units can also be woven into the bodysuit with conductivethread so that they can be connected to the sub-control units and thesewable connections are sewed together.

FIG. 14 shows one possible solution of sending power, data and pulses tothe sub-control units by using a serial data-bus. It is possible tosuperpose data on the power sent to the sub-control units (power 3V3, 5Vand GND) so that the master unit can send out data with instructions tothe sub-control units about what the sub-control units should do. Whenthe instructions have been received by a particular sub-control unitthen, based on the instructions in the data, it knows, when it receivesa first pulse at a higher voltage level (such as 20-40V), that it shallsend the pulse to the first electrode pair that is are in the programmedtransmission list of the instructions. When the second pulse arrives tothe sub-control unit sends the second pulse to the next pair ofelectrodes listed in the instruction list etc. Preferably, thestimulation pulses are always at a higher voltage level than the powervoltage and data pulses so that the sub-control unit can easilydistinguish the stimulation pulses from the data pulses and powerpulses. Data information is preferably sent at a high frequency to theCPU of the sub-control unit. The use of only two wires is merely anexample of a suitable solution but more than two wires may also be used.For example, three wires may be used to each sub-control unit whereintwo wires are used for power, positive and negative pole and data andthe third wire is used for sending the pulse. Data instructions may alsobe sent by using wireless communication technology such as Wi-fi,Bluetooth etc. It is also possible to use two wires wherein the twowires are used to send both power and pulses while the data is sent bywireless communication technology such as Wi-fi, Bluetooth etc. Aportion of pulse signal 512 to the sub-control unit 122 is shown in FIG.14 to illustrate the pulse 494 and a time gap 498 between data andstimulation pulses. It is possible for the master unit 266 to send dataunits 530 between the high voltage stimulation pulses to the sub-controlunit such as sub-control unit 122 (see FIG. 5) that receives the dataunits 530 via extensions 124 b, 130 b and wires 124 a, 130 a,respectively, from the master unit 266. The data units 530 arepreferably sent to the sub-control units during the start up so that thesub-control units receive instructions in the data units about which andwhen electrodes should be activated. In other words, the data units 530are first sent to the sub-control units with instructions about what todo with the pulses 494 that comes after the data units 530. The masterunit 266 may provide power to the sub-control units via the wiresextending from the master unit to the sub-control units. The data unitsmay include information about to which electrodes and which combinationsof electrodes and pulse length, the sub-control unit should distributethe pulses 494 to when they arrive from the CPU of the master unit 266.All the sub-control units receive the data but they have differentaddresses so the master unit can address the data to the right subcontrol unit. If the data information has the wrong address for asub-control unit then the sub-control unit does not read it. No datashould be sent during the stimulation pulses and, preferably, thestimulation pulses to the sub-control units are generated from themaster unit 266 that also controls the data flow. As indicated above,instead of using a serial data-bus with two wires, it is possible toalso use three wires wherein two of the wires are used for power whilethe third wire is use to carry the stimulation pulses and that data canbe sent via a suitable wireless technology. It is also possible to usetwo wires used to provide the power while the data is sent by wirelesstechnology. It is also possible to use a one-wire data transmission suchas sending data between the master unit and the sub-control unit in thepositive or negative wire. The body suit can also have multiple masterunits so that, for example, one master unit stimulates an arm and theother master unit is used to stimulate the legs. The master unit canalso have several power, data and pulse outputs circuits so that itdrives several independent circuits such as running the front part ofthe suit independent from the back side of the suit or the upper part ofthe suit independent from the lower part of the suit.

FIG. 15 is a schematic illustration of how the direction of the currentbetween two electrodes via a muscle can be changed so that a positivepole is changed to a negative pole and vice versa. It may also bepossible to intermittently switch the current flow so that the currentfirst flows from an insertion or first end of the muscle to an origin orsecond opposite end of the muscle and then from the origin or second endto the insertion or first end i.e. the current goes back and forththrough the muscle. It may also be possible run in one direction formore than one cycle before the direction is switched to the oppositedirection. An important and surprising insight is that the switching ofthe direction of the current improves the effectiveness of thestimulation by reducing the build-up of natural resistance in thetreated/stimulated muscle over time and reduces the risk of redirritations being created on the skin of the patient. It has beendiscovered that the muscles have a capacitor effect in the muscle,similar to a capacitor. Preferably, the CPU 531 of the sub-control unit122 determines which current direction should be used based oninstructions received from the master unit 266. It is possible to switchthe direction during each stimulation pulse, such as after 50% of thepulse length the polarity is shifted or shifted several times during onepulse. It is possible to switch the direction after each stimulationpulse that is sent to the electrodes or numerous pulses may be sent,such as 10 pulses, before the direction of the current is switched andthen, for example, send another 10 pulses before the direction isswitched again. It is of course possible to run the current in the samedirection through the muscles without switching the direction.

The CPU 531 of sub-control unit 122 receives power from the master unit266 via power line 533 and also the pulse (see pulse input 782 in FIG.16) so that the CPU knows that a pulse has arrived to the sub-controlunit. With reference to FIG. 15, the unit 122 has an output unit 535that receives the pulse signal 512 sent from the output 537 of themaster unit 266. The output unit 535 has a ground 706. The pulsestimulation signal 512 from the master unit 266 is sent via arrangement513 shown in FIG. 10. The CPU 531 of the sub-control unit 122 has an I/Ounit 539 that sends instructions about when to send out pulses via line543 to the output unit 535. More particularly, the unit 539 may send outeither a “0” instruction or a “1” instruction wherein the “1”instruction that may represent that the output unit 535 leads out thestimulation output pulse for a certain time period to forward theincoming stimulation pulse 512 from the master unit 266 to theelectrodes. The “0” instruction may represent that the output unit 535is switched to a closed position to close the output function so that nostimulation pulse signal 512 can pass through the output unit 535. TheCPU unit 531 also has an I/O unit 541 that sends out “0” or “1”instruction about which current direction to use via line 545 to theoutput unit 535. The “0” instruction may represent one direction whilethe “1” may represent the opposite current direction. If electrode 134is the positive pole and electrode 136 is the negative pole then thecurrent flows from output unit 535 to electrode 134 via wire 134 athrough the muscle and into electrode 136 and via wire 136 a back tooutput unit 535 of sub-control unit 122 to ground (GND). The arrows 702and 704 between the electrodes 134, 136 indicate that the direction ofthe current flow can be changed. As shown in FIG. 5, the sub-controlunit 122 is not limited to just extensions 134 b, 136 b that areconnected to electrodes 134 a, 136 a, respectively but preferably has atleast 8 such extensions. It is also possible to create combinations sothat, for example, electrodes 134 or 136 are combined with one or manyother electrodes so that complex treatment patterns may be created bythe CPU 531 with instructions from the CPU in the master unit 266.

FIG. 17 illustrate how a distribution unit 770 can receive power, dataand pulses and distributes signals to the CPU 531 and output units 535of the sub-control units such as sub-control unit 122 (also shown inFIG. 15). In general, the serial data-bus information (i.e. power, dataand pulses) that are eventually transmitted in, for example, the twowires 124, 130 are first split up or divided into five separate linesthat are connected to the CPU and the output units of the sub-controlunit. Preferably, the distribution unit 770 is part of the sub-controlunit 122 and a part of the master unit 266 unit. FIG. 16 is similar toFIG. 15 but shows more details and includes 8 electrodes 134, 136, 138,140, 142, 144, 146 and 148 instead of just 2 electrodes 134, 136 andfour output units 535 a, 535 b, 535 c, 535 d instead of just the oneoutput unit 535 shown in FIG. 15. In this system, the master unit 266 iscommunicating with the sub-control units and electrodes by using onlytwo wires, such as wires 124 and 130 in FIG. 17, that are electricallyconnected to all the sub-control units in the bodysuit and other wirepairs going to the master unit 266. One wire, such as wire 124 in FIG.17, could carry VCC power at, for example, +3.3V, data1 pulses 530 andthe stimulation pulses 494 received from the master unit 266 to thesub-control units. The other wire, such as wire 130, could serve asground (GND) and carry data2 pulses 772. The data 1 pulses 530 and data2 pulses 772 relate to communication between the master unit and all thesub-control units. Other data bus constructions may also be used. Theunit 770 separates data1 pulses 530 from VCC by unit C1 so that the datagoes to a data input Data IN 1 774 of the CPU 531 (best shown in FIG.16). Data2 pulses 772 are separated from GND by unit 770 by unit C2 toan input Data IN 2 776 of the CPU 531. The pulses 494 of stimulationsignals 512 to the electrodes are sent in to the sub control unit whenno data is sent. This pulse 494 is read by the CPU 531 at input 782 viaresistor 780 and zener diode D1 (in FIG. 16) to a pulse input 782. Thispulse 494 also goes to the 535 a, 535 b, 535 c and 535 d as pulse-in 796and as pulse-out 798 to the electrodes when the sub-control unit sendsout the pulses. The CPU 531 can keep the pulse length of the stimulationsignal 512 the same or shorten it by activating the allow pulse-out 794function. The same principle applies to all the other output units 535b-d.

The arrangement 770 in FIG. 17 provides a protection of the electroniccomponents so that the high voltage pulse does not destroy any componentthat cannot withstand the high voltage. The unit 770 distributes a VCCpower signal 784 (such as +3.3V) to the sub-control units 122 to providepower to the components of the sub-control unit 122 and ground via GND786. The CPU controls the current direction of output units 535 a, 535b, 535 c and 535 d regarding the current direction 788 a, 788 b, 788 c,788 d of the electrodes and how to switch the polarity of the electrodes134,136,138,140,142,144,146 and 148 in FIG. 16 as illustrated by thearrows between the electrodes. Only arrows 790, 791, 792 and 793illustrate that the electrode pair may also change so that, for example,electrode 134 is paired with electrode 138 instead of with electrode136. It is to be understood, that the electrodes may be paired in anycombination and that the electrode pairs 134 and 136 and electrode pairs134 and 138 are merely examples. This means electrode 134 may, forexample, be the positive pole while electrode 138 is the negative pole.The electrode 134 may be paired with any other electrode. It isimportant that the electrodes may change polarity in order to make itpossible to pair any of the electrodes with one another since oneelectrode must be the positive pole and the paired electrode must be thenegative pole. The change of polarity of the electrodes makes itpossible to stimulate the muscles in new and different ways. This is notpossible to do when the polarity of the electrodes is fixed.

The serial data 1 and 2 between the master unit and the sub-control unitinclude information about how the pulses should be sent out from thesub-control unit to the electrodes. When a stimulation pulse arrives tothe sub-control unit via pulse input 778, the CPU 531 must first realizeor be activated by the stimulation pulse that has arrived to thesub-control unit. This is determined by input 782. Then the CPU of thesub-control unit selects to which electrode pair the stimulation pulseshould be sent to and the CPU sets the current direction and then theCPU allows the stimulation pulse to pass to pulse out on units 535 a,535 b,535 c or 535 d. Preferably, the pulse length or duty cycle (suchas 200 microseconds) of the stimulation pulse received from the masterunit via line 778 should be slightly longer than the max pulse length(such as 175 microseconds) of the stimulation pulse that is sent fromthe output unit 535 a to the electrode 134 and 136. The exact values ofthe pulse lengths are not important as long as the pulse length of theincoming pulse is slightly longer than the outgoing pulse to theelectrodes. The sub-control unit knows the stimulation pulse length sothat the sub-control unit sets the correct pulse length. The difference(such as 25 microseconds) in the pulse length enables the output unit535 a to receive the incoming stimulation pulse and send the stimulationpulse to the correct electrode and with correct length.

FIG. 18 is a schematic view of the body suit 100 reading the brainsignals 800 of the patient who wears the body suit 100 so that theelectrodes measures the weak voltage signals from the brain. Only theupper part of the body suit 100 is shown in FIG. 18 and the otherportions of the body suit 100 are identical to the body suit shown inFIG. 4 that also includes all the reference numerals. The suit 100 has asixth connector 802 that has a positive pole 804 electrically connectedto wire 155 via an elastic and flexible wire 806 and a negative pole 808electrically connected to wire 157 via an elastic and flexible wire 810.The sixth connector 802 has a positive pole 812 that is electricallyconnected to a seventh sub-control unit 814 via an elastic and flexiblewire 816 and a negative pole 818 that is electrically connected to thesub-control unit 814 via an elastic and flexible wire 820. Thesub-control unit 814 is different from the other sub-control units inthat is does not have any muscle stimulation function but is used toreceive information from the electrodes about the brain signal activityof the brain 800 and transmits this information via the serial data-busto the master unit 266. The master unit 266 receives the information anddetermines which stimulation that should be activated. The sub-controlunit 814 can provide input to the system so that the system can perceivewith the help of these signals which body parts the person wearing thebody suit wants to move. This is where the master unit 266 steps in tointerpret the brain voltage signals (EEG signals) sensed by theelectrodes inside the headband 832 or at the lower neck level or upperspinal cord to learn which muscles that must be activated to carry outthe desired muscle movement such as moving an arm. The present inventionis not limited to merely reading signals at the brain level. It is alsopossible to use the body suit to read the signals that the brain send atthe lower neck level or upper spinal cord in order to read request formovements without requiring the patient wear a heatset or head-piecewith electrodes. The body suit can be used to measure signals at upperneck muscles, jaw muscles, sternocleido mastoideos and stratetiusmuscles to read brain signals without needing a headset

The master unit 266 may have a database that includes previouslyrecorded and stored brain voltage wave patterns for various musclemovements so that when a certain brain voltage wave pattern is received,the master unit may first analyze the pattern of the incoming brainsignals and then search its database to find the matching brain signalspattern that is then translated into which electrodes should beactivated and in which order to carry out the desired muscle movement orstimulation such as the movement illustrated in FIG. 9. The sub-controlunit 814 contains a CPU that saves and analyzes the incoming data fromthe electrodes 824, 828 and send data to master unit 266 that determinewhich electrodes should be activated in the suit. It should beunderstood that sub-control unit 814 sends out data via the serialdata-bus to the master unit 266 when the master unit asks for data.

Similar to the sub-control units in the modules, the sub-control unit814 is electrically connected via a wire 822 to an electrode 824 and viaa wire 826 to another electrode 828. It should be understood that morethan two wires may be used between the sub-control unit 814 and theconnector 802. The electrodes are preferably urged against the head 830by an elastic headband 832. FIG. 18 illustrates only two electrodes butmany more electrodes may be used as required to monitor the brainvoltage signals of the brain 800 to determine which muscles the personis thinking about using. The body suit may be used to read signals atsternocleidomastoid muscle, temporalis muscle, masseter muscle,trapezius muscle, suboccipital muscles, cervical spinal erector muscles.The body suit can be used to conduct measurement of key muscles in headand neck.

EMG measurements in a first muscle can be recorded and stored. Therecording of EMG-activation can be paired to activation of any othermuscle in the patient/user by using the electrodes in the suit.Activation of any other muscle, through the suit electrodes, can beconnected to activate of the first muscle. For example, the user couldclench the teeth and so forth activate the masseter muscle. The EMGsignal from masseter could be the starting signal to activatecontraction of knee extensor muscles. A patient/user with tetraparesis,after cervical spinal cord injury, could regain the ability to standthrough activation of jaw closing muscles. Another example is that theshrugging of shoulders leads to activation of the trapezius muscle,measured by EMG-electrodes in the bodysuit. Activation of trapeziuscould be paired to activation of the arm-lifting and elbow-flexingmuscles. In this example, the shrugging of the shoulder could lead tothe user giving someone a hug.

FIG. 19 is a schematic illustration of the master unit 266 that,preferably, includes a disposable or re-chargeable battery 850, such as6-10 volts (or higher), to electrically drive the master unit 266 andall sub-control units. Preferably, the battery cannot be charged whilein the master unit and in the suit to prevent any undesirable voltagegoing into the bodysuit 100 during charging. An external battery chargershould be used. The battery 850 is electrically connected to the powerunit 852 that provides the power to the central processing unit (CPU)854, display 860 and all the master unit circuitry 513 (also shown inFIG. 10) and all sub-control units. The power module or unit 852 alsohas a step-up voltage circuit 856 that steps up the voltage of thestimulation pulse voltage 511, that uses to generate stimulation pulse512 sent to the sub-control unit to, for example, about 20V or 40Vwherein the power voltage to the arrangement circuit 513 and CPU may,for example, be 3.3V or 5V. In other words, the circuit 856 increasesthe voltage of the battery such as 3-10V to about 20-40V. The exactvoltage used in the stimulation pulse 512 is determined by the CPU 854and its software. The master unit 266 also has a safety circuit modulein hardware 858 that makes sure no pulse length in the stimulation pulseis longer than a predetermined maximum time period. The reference to CPUin arrangement 513 in FIG. 10 means there is an electrical connection tothe CPU 854 that controls the input/output to receives information fromand send information to the arrangement 513. The master unit has a userinterface unit 860 that is an interface so that the therapist can set,see and change parameters and programs of the master unit and alsoreceive the data from the master unit collected during earlierstimulating runs. The display unit 860 may include a display window 862,switches as start/stop 864 that starts or stops the running of thestimulation program such as a stimulation program and makes it possibleto select and change stimulation programs and pause the run of thestimulation program. The unit 860 has a buzzer 866 that providessound/warning signals and LED diodes 868 as indicators. The master unit266 also has a communication module 870 for Bluetooth, Wi-fi and USBdata connections in order to communicate with the sub-control units inthe bodysuit 100 and with computers as PC, pad or phones and with theInternet and cloud services. The master unit 266 has an interface 872that connects all the wiring that goes to the sub-control units to sendfive types of signals including power, positive pole, negative pole,superposed data and stimulation pulses equivalent to FIG. 17 (see ref.no. 770).

FIG. 20 is substantially similar to FIG. 9 but includes a movementsensor 517 that registers movement of the arm 509. The movement sensorsmay be placed on any part of the body suit 100 where measurement ofmovements is desired, the placement of the sensor 517 on the elbow ofthe arm 509 is merely an illustrative example. Information about themovement sensed by the sensor 517 is sent to the sub-control unit 122via wires 519, 521 and provides feedback to the sub-control unit 122regarding the effect of stimulation signal 512 on the body movement whenthe signal 512 is strong enough to cause muscle 502 to contract in orderto move the arm 509 or when the user of the body-suit can move the arm.In this way, the sub-control unit receives information about whether thearm has moved and how much it has been moved. With the movement sensorsthe system can obtain information about movement even micro-movementscreated with the stimulation pulses. This information is also be sent tothe master unit 266 so that the parameters of the stimulation signal 512can be adjusted accordingly. It is also possible to merely readmicro-movements at the muscle level to determine whether the“sweet-spot” has been reached i.e. the correct stimulation of the musclethat triggers the response from the spinal cord without causing aphysical movement of, for example, the arm.

FIG. 21 is a schematic view of a frontside of a garment of an elasticand tight body suit 1000 of the present invention. The body suit 1000 issubstantially similar to body suit 100 shown in FIGS. 4 and 18 exceptthat body suit 1000 also includes a right-hand glove module 1002,left-hand glove module 1004, right sock module 1006 and a left sockmodule 1008. The detailed description of body suit 100 also applies tobody suit 1000. For clarity, only the differences between body suit 1000and body suit 100 are here described. One important feature of body suit1000 is that it enables the patient wearing the suit to move the hands,fingers, feet and toes by reading brain signals and by electricallyrelaxing and stimulating muscles, as described in detail above. Thesub-control unit 122 of right arm module 102 has an elastic and flexiblewire 1010 electrically connected to a positive pole 1012 of a right-handconnector 1014 and an elastic and flexible wire 1016 electricallyconnected to a negative pole 1018 of the right-hand connector 1014.Similar to the other connectors described in detail above, right-handconnector 1014 electrically connects the right-hand glove module 1002 tothe right arm module 102.

Right-hand glove module 1002 has a right-hand sub-control unit 1020 thatis electrically connected to electrodes 1022, 1024 and 1026 via elasticand flexible wires 1022 a, 1024 a and 1026 a to relax and stimulatemuscles in the hand 1028, as described in detail above. The sub-controlunit 1020 is electrically connected to a positive pole 1030 and to anegative pole 1032. The sub-control unit is here shown with 3 electrodesbut it can have more or fewer electrodes. This applies to all thesub-control units of FIG. 21.

The sub-control unit 228 of left arm module 106 has an elastic andflexible wire 1034 electrically connected to a positive pole 1036 of aleft-hand connector 1038 and an elastic and flexible wire 1040electrically connected to a negative pole 1042 of the left-handconnector 1038. The left-hand connector 1038 electrically connects theleft-hand glove module 1004 to the left arm module 106. Left-hand glovemodule 1004 has a left-hand sub-control unit 1044 that is electricallyconnected to electrodes 1046, 1048 and 1050 via elastic and flexiblewires 1046 a, 1048 a and 1050 a to relax and stimulate muscles in thehand 1052, as described in detail above. The sub-control unit 1044 iselectrically connected to a positive pole 1054 and to a negative pole1056.

The sub-control unit 294 of right leg module 110 has an elastic andflexible wire 1058 electrically connected to a positive pole 1060 of aright-foot connector 1062 and an elastic and flexible wire 1064electrically connected to a negative pole 1066 of the right-footconnector 1062. The right-foot connector 1062 electrically connects theright-sock module 1006 to the right leg module 110. Right sock module1006 has a right-foot sub-control unit 1068 that is electricallyconnected to electrodes 1070, 1072, 1074 and 1076 via elastic andflexible wires 1070 a, 1072 a, 1074 a and 1076 a to relax and stimulatemuscles in the right foot 1078, as described in detail above. Thesub-control unit 1068 is electrically connected to a positive pole 1080and to a negative pole 1082.

The sub-control unit 320 of left leg module 112 has an elastic andflexible wire 1084 electrically connected to a positive pole 1086 of aleft-foot connector 1088 and an elastic and flexible wire 1090electrically connected to a negative pole 1092 of the left-footconnector 1088. The left-foot connector 1088 electrically connects theleft sock module 1008 to the left leg module 112. Left-sock module 1008has a left-foot sub-control unit 1094 that is electrically connected toelectrodes 1096, 1098, 1100 and 1102 via elastic and flexible wires 1096a, 1098 a, 1100 a and 1102 a to relax and stimulate muscles in the rightfoot 1104, as described in detail above. The sub-control unit 1094 iselectrically connected to a positive pole 1106 and to a negative pole1108. It is thus also possible to measure movements and voltage signalsfrom the feet and hands of the patient wearing the body suit.

Because the body suit 1000 of the present invention has sub-controlunits it is possible to extend the stimulation to the hands and feet byactivating electrodes on the glove and sock modules. It is also possibleto remove one module such as arm module 102 and electrically connectconnector 128 directly to right-hand connector 1014 so that the masterunit 266 can communicate with the sub-control unit 1020 to control theelectrodes connected to the sub-control unit 1020. This principle ofremoval of a module applies to all the other modules i.e. that onemodule can be removed and then the connectors can be directly connectedto one another.

In operation, it is possible to ramp up or gradually increase the pulselength, voltage level of the stimulation pulse and the current levelsuch as in the beginning of the stimulation treatment to make thetreatment more comfortable to the patient. In other word, the treatmentstarts with a mild stimulation that is gradually increased to make thestimulation signal more powerful when the patient has become used tofeeling the stimulation signal. When necessary it is also possible toramp down the pulse length, voltage level of the stimulation pulse andthe current such as at the end of the treatment or when the stimulationpulse is too strong or powerful to the patient (i.e. when thestimulation signal causes undesirable movement of, for example, an arm).More particularly, when the arrangement 513 is in the current mode, itis effective to gradually increase the current as set by the currentlimits in signal 759 assuming that the voltage of pulse power 511 ishigh enough for the current at the stop limit current 518. The rampingup period may be between 5-10 minutes before the full treatment currentis reached. The treatment period may be 40-60 minutes. The treatmentperiod may be longer or shorter. When the treatment period is over, itis possible to ramp down i.e. gradually reduce the current for 5-10minutes by gradually lowering the current limits in signal 759 to makeit comfortable to the patient. The pulse length may also be ramped up ina similar way so if the pulse length is 175 microseconds the first pulsemay be 30-50 microseconds long and this is gradually increased until thefull pulse length is reached in 5-10 minutes. The pulse length can alsobe ramped down at the end of the treatment in a similar way over 5-10minutes. The ramping up and down of the pulse length applies to both thevoltage mode and the current mode. It is less effective to raise thevoltage of the pulse power 511 when the arrangement 513 is in thecurrent mode because the arrangement 513 is then self-regulating and thecomparator 756 sets the current as the result of the current limit levelprovided in signal 759. The only voltage requirement, when in thecurrent mode, is that it must be high enough to accomplish the stopcurrent 518. When the current of the stimulation signal 512 is ramped upthis is reflected in the pulse current value signal 752 (see FIG. 10)that goes to the CPU of the master unit 266 so that the CPU receives thefeedback that the current is actually gradually being increased as aresult of raising in the current limit in signal 759 that is also sentby the CPU of the master unit 266. Because the fluctuations betweencurrent start 516 and current stop 518 are shorter (in nanosecondsrange) than the pulse length 495, the voltage value in signal 752represents an average of the voltage or the equivalent current thatfluctuates between the current start 516 and current stop 518. In thisway, the pulse current average value signal 752 acts as a feedbacksignal to the change of the current level in signal 759. Thecorresponding current value in signal 752 is particularly important whenthe arrangement 513 is in the voltage mode because then the value of theactual current flowing in one pulse through the muscle is unknown or atleast difficult to control, as shown in FIG. 11C. When in the voltagemode and if the corresponding average current in signal 752 is too highthen the CPU of the master unit 266 can lower the voltage of the pulsepower 511. Similarly, when the average current is too low, as reportedin signal 752, then the CPU can increase the voltage of pulse power 511when in the voltage mode until the desired current is reached althoughit is difficult to know the exact current that flows through the musclein each pulse, as shown in FIG. 11C.

When in the current mode and if the current in stimulation signal 512 istoo high then movement sensor 517 (see FIG. 20) can sense a movement orcontraction of a muscle, for example, the arm 509 as reporting insignals 519, 521 going to the sub-control unit 122 and the sub-controlunit 122 forwards the movement information to the master unit 266 thatlowers the current limits in signal 759 going to the comparator 756 ofcircuit U1 when the arrangement 513 is in the current mode (see FIG. 10)the sub-control unit can also shorten the pulse length to lower thestimulation. When the current is too high and the arrangement 513 is inthe current mode (signal 750 is in “1” mode) then it may also beeffective for the CPU of the master unit 266 to shorten the duty cycleor pulse length 495 of each pulse 494 of the stimulation signal 512 orlowering the current limit level 759. It is also possible for the CPU ofthe master unit 266 to shorten the pulse length when the arrangement 513is in the voltage mode although the current that flows through themuscle includes the peak 521 (see FIG. 11C) in the beginning of thepulse so a slight shortening of the pulse length does not remove thepeak 521 so the stimulation signal may still be uncomfortable to thepatient wearing the body suit even when the pulse length has beenslightly shortened such as from 175 microseconds to 100 microsecondssince the current peak 521 occurs in the beginning of the pulse 494. Thecurrent mode does not have this drawback because the current onlyfluctuates between the current start 516 and current stop 518 (see FIG.11B).

It is also possible to measure the difference between the voltagesignals from electrodes 138, 140 that are mounted on the antagonistmuscle 508. This voltage difference is amplified by amplifier 127 (seeFIG. 9) and stored in the sub-control unit 122. The sub-control unit 122may then at time intervals report the voltage differences to the masterunit 266 so that the master unit can determine whether the parameters ofthe stimulation signal 512 of muscle 502 should be changed. If thevoltage difference is high this means the muscle 508 is not sufficientlyrelaxed and the stimulation of muscle 502 should increase by raising theparameters of the signal 512 such as raising the current when thearrangement 513 is in the current mode or raising the voltage when thearrangement 513 is in the voltage mode.

It is also possible to connect more than one master unit to the bodysuitso that one master unit runs a first program in a first module of thebodysuit and a second master unit runs a second program in a secondmodule wherein the second program is different from the first program.In this way, the stimulation pulses, frequencies etc. associated withthe first program are independent of the stimulation pulses, frequenciesassociated with the second program. Many master units can be connectedto the connectors of the bodysuit. If only the arm module is used thenthe master unit 266 can be connected at connector 128 or connector 194.Preferably, the master unit is or the master units are connectable toany of the connectors on the body suit.

FIGS. 22A-22C illustrate the drawbacks of using the voltage mode. It isto be understood that the resistance values of the electrodes andmuscles are merely illustrative example to explain the principles of thepresent invention. Other resistance values may also be used. Withreference to FIG. 22A and as explained in detail regarding FIGS.11C-11D, the initial current (when the arrangement 513 is in the voltagemode) that runs through the muscle reaches a peak value 521 during thepulse flank that may, for example, be about 25 mA that rapidly decreasesto the working current level 525 that may, for example, be about 3 mAwhen the internal resistance in the electrodes is about 100 Ohm, themuscle resistance is about 6500 Ohm and the pulse voltage is 20V. Inthis example, about 0.3V is lost in each electrode. The internalresistance in each electrode could increase to about 1000 Ohm or anyvalue higher substantially than 1000 Ohm. When the resistance is 1000Ohm, the current is 20V/8500 Ohm=2.35 mA which is the maximum currentgoing through the muscle. Because the muscle is like a capacitor themaximum charging current is not more than 10 mA (20V/2000 Ohm=10 mAbecause the capacitance is between the electrodes through the muscle.The level of the current maximum after the peak 521 is dependent on thetotal resistance (i.e. the resistance of the electrodes plus muscleresistance). In the above example, the resistance is about 6500 Ohm inthe muscle and 1000 Ohm in each electrode so that the maximum current isthen 2.35 mA (20V/8500 Ohm=2.35 mA) as shown by curve 523 in FIG. 22A.

FIG. 22B illustrates the voltage across the electrode when theelectrodes have an internal resistance of 100 Ohm each and how thevoltage gradually increases to a voltage level 527 such as 19.4V whichis lower than the voltage 20V. This is because the voltage drop in theelectrodes is 0.3V in each electrode (3 mA×100 Ohm=0.3V) of the pulses494 of the stimulation signal 512. The reduction of the current peakincreases the voltage drop at the electrodes. FIG. 22C illustrates themuscle and electrodes with a resistance of 100 Ohm each when the voltagemode is used. If the peak current is 25 mA (charging the capacitance)and each electrode 134, 136 has an electrode resistance of 100 Ohm then2.5V of the voltage is lost at each electrode 134, 136 during the peaktop so the voltage is 15V between electrodes and at the muscle, as shownin FIG. 22B. When the current decreases during the pulse the voltageincreases between electrodes and over the muscle 502, as illustrated byFIG. 22B. At a current level of 3 mA, about 0.3V is lost at eachelectrode 134, 136 when the resistance of each electrode is 100 Ohmwhich explains why the voltage 527 across the muscle 502 only reaches19.4V in FIG. 22B. If the total resistance through the muscle 502 isabout 6500 Ohm and the electrodes 134, 136 each has a resistance of 1000Ohm each then there is a total resistance of 8500 Ohm in the circuit.The resulting maximum current, when voltage the pulses 494 is at 20V andthe total resistance is 8500 Ohm, is 2.35 mA as shown by curve 523 inFIG. 22A and illustrated in FIG. 22D. FIG. 22D is identical to FIG. 22Cexcept that the resistance of electrodes 134, 136 has increased from 100Ohm to 1000 Ohm. Again, because the muscle is like a capacitor thecharging current is maximum 10 mA when the electrodes have a resistanceof 1000 Ohm each (20V pulse/electrode resistance 2000 Ohm=10 mA and thisbecause there is capacitance between the electrodes through the muscle).FIGS. 22A and 22B thus illustrate the drawbacks of using the voltagemode because the current cannot be controlled as it can when thearrangement 513 is in the current mode.

Another very important feature of the present invention is that thearrangement 513 (shown in FIG. 10) may be included in each sub-controlunit such as sub-control unit 122 shown in FIG. 23. This signals 750,754 and 759 come from the CPU of the sub-control unit instead of the CPUof the master unit. Preferably, the CPU of the sub-control units receiveinstructions from the CPU of the master unit about how the signals 750,754 and 759 should be adjusted or set. The inclusion of the arrangement513 at each sub-control unit makes it possible to run a first current ata first sub-control unit that is different from a second current at asecond sub-control unit because the signal 759 at each sub-control unitsets the current limits as explained in detail above regarding FIG. 10.Additionally, the CPU of each sub-control unit can also set the pulselength via switch SW1, as explained in detail above.

It is possible to add a volt regulating circuit in the sub-control unitsso that the sub-control units may adjust (lower) the voltage of thepulse 512 that is received from the master unit. For example, when thearrangement is in the voltage mode, the sub-control unit can set amaximum level of the pulse voltage going to units 535 a,535 b,535 c and535 d through the switch SW1. When the arrangement is in the currentmode the voltage is set to the maximum value and the current is set bythe arrangement that in turn affects the voltage of the stimulationsignal so that the current is constant, as explained in connection withFIG. 10. All the information about what the sub-control unit should dois received as instructions from the master unit that in turn receivesinput information from the therapist that sets the stimulation patternfor the patient from a PC stimulation software program that sendsinstructions to the master unit.

FIG. 23 shows a modified sub-control unit 122′ that includes anarrangement 513′ that is substantially similar to the arrangement 513(shown FIG. 10) so that the unit 122′ can adjust (lower) the voltage,the pulse length and the current (when in the current mode). Moreparticularly, stimulation pulse signal 512 arrives from the master unit266 from switch SW1 shown in FIG. 24. The CPU 531 receives thestimulation signal 512 at pulse input 782. The CPU 531 is electricallyconnected to the output units 535 a, 535 b, 535 c, 535 d. The details ofthe output units are described in connection with FIG. 16 and apply tothe output units in FIG. 23 also. The CPU 531 may keep or lower thevoltage of the stimulation pulse signal 512 by sending a pulse voltagelevel control signal 1110 to a pulse voltage control circuit 1112 sothat the voltage of the stimulation pulse signal 512 at pulse in 1114remains the same or is lowered at pulse out 1116. For example, thecircuit 1112 can lower the voltage of the stimulation signal from, forexample, 60V to another voltage value such as 20V. The circuit 1112 canalso keep the voltage of the stimulation signal 512 unchanged. Asdescribed in detail in FIG. 10, it is not important change the voltagewhen the arrangement 513′ is in the current mode.

The CPU 531 may send a pulse control signal 754′ to switch the switchSW1 between an open position and a closed position in the same way assignal 754 described in detail in FIG. 10 and it can also be switched tobe on all the time because it is a pulse that comes from the masterunit. In this way, the CPU 531 can shorten the pulse length 495 ofstimulation signal 512 so that stimulation signal 512′ leaving theswitch SW1 has a shorter pulse length 498′. The switch SW1 can also keepthe pulse length the same i.e. the same as the pulse length ofstimulation signal 512 by activating the switch to be on all the time.The output units 535 a, 535 b, 535 c, 535 d receives the stimulationsignal 512′ and can keep the pulse length the same or shorten the pulselength received from the CPU further by activating allow pulse-outfunctions 794 a. 794 b, 794 c and 794 d, respectively, as described inFIG. 16. The CPU 531 can switch the arrangement 513′ between a currentmode and voltage mode by sending a control signal 750′ to switch SW2, asdescribed in FIG. 10. The CPU 531 can set the current limit by sendingthe signal 759′ to the comparator 756′ and a feedback signal 752′ issent back to CPU 531 to inform the CPU 531 about the current level. Allthe principles that apply to arrangement 513 also apply to arrangement513′ and are therefore not described here.

The output units 535 a-d are electrically connected to electrodes134-148. The details are shown in FIG. 16 and all the details of FIG. 16also apply to FIG. 23 although some details have been omitted from FIG.23 for clarity. The unit 535 a-d are electrically connected to feedbackcircuits 1118 a, 1118 b, 1118 c and 1118 d that measure EMG signals i.e.the natural very small voltage signals from the muscles, as described inFIG. 9. Preferably, each feedback circuit includes a switch andamplifier to switch the amplifier in and out that measures the naturalvoltage signals from the muscles. The circuits 1118 a-d send feedbacksignals 1120 a, 1120 b, 1120 c and 1120 d to the CPU 531 so the CPU candetermine whether to change the voltage, pulse length or current of thestimulation signal 512′.

FIG. 24 shows a simplified switch arrangement 513″ of the master unitthat can be used when the sub-control units include the arrangement513′. In other words, the master unit can be simplified to merely sendout stimulation pulses. The main function of arrangement 513″ is tocreate the pulses of stimulation signal 512 from pulse power 511. Forexample, the arrangement 513″ does not include the circuitry U1 or aswitch SW2 to switch the arrangement between a current mode and avoltage mode. The arrangement 513″ is always in the voltage mode andcreates stimulation pulses 512 by opening and closing switch SW1, asdescribed in connection with FIG. 10. Preferably, the master unit 266still send out the pulsating stimulation signal 512 to the sub-controlunits for safety reason. If each sub-control unit would generate thestimulation voltage such as 40V the risk increases that something couldgo wrong which is very uncomfortable to the user. It is safer to havethe master unit generate the stimulation voltage because it has separatehardware that makes such the voltage does not exceed certain presetlimits. The master unit also has hardware that controls the pulse lengthto make sure it does not exceed a preset limit. This provides bettersafety compared to generating the high voltage signal in eachsub-control unit.

Preferably, the voltage of signal 512 is higher than what is needed tostimulate the muscles because the circuit 1112 at each sub-control unitcan lower the voltage to a desired level. In this way, it is possible touse a first voltage level at a first sub-control unit and a secondvoltage level at a second sub-control unit that is different from thefirst voltage level. However, the master unit sets the maximum pulselength and the maximum voltage in the stimulation signal and the localCPU at the sub-control unit can only keep the same values or lower thevoltage or shorten the pulse length. Additionally, the CPU of thesub-control unit can set the current limit i.e. it can increase ordecrease the current as desired as long as there is sufficient voltagein the stimulation signal from the master unit. Because each output unithas its own allow pulse out function, it is possible to use a firstpulse length to the first pair of electrodes (i.e. electrodes 134, 136)and a second different pulse length to the second pair of electrodes(i.e. electrodes 138, 140) because the allow pulse out function can beset at different values for each output unit 535. If, for example, thepulse length of the stimulation pulse 512 is 200 microseconds, the pulselength can first be shortened at switch SW1 to, for example, 180microseconds and then further shortened to, for example, 175microseconds by using the allow pulse-out 794 function of the outputunit, Each pulse in the stimulation signal 512 is sent to allsub-control units so that pulse 1 is used by sub-control units 1 and 3while the second pulse is used by sub-control unit 2 etc. This meansthat sub-control unit 2 does not send out pulse 1 to the electrodes thatthe master unit selected by serial data communication to the sub-controlunit.

The master unit sends data to all the sub-control unit and to each onewhen the sub-control units have a separate address. The sub-controlunits receive information about to which electrode or electrodes shouldreceive the stimulation signal and in which order. For example,sub-control units 1 and 3 may be instructed to simultaneously send pulse1 to electrodes and sub-control unit 2 may send out pulse 2 to itselectrodes according to stimulation 1 of its list of stimulation pulsesthat are to be sent to the electrodes. This principle applies to all thesub-control units and all the sub-control units receive instructionsabout which pulse they should send out according to the list ofstimulations that the master unit has sent them. If sub-control unit 1uses pulse 1 and 2 as the first stimulation pulse signal and sub-controlunit 2 uses pulse 3 and 4 to send out pulses while sub-control unit 3uses pulse 5 and 6 to send out pulses and when there are only 3sub-control unit in use then the 7 pulse is sent out by sub-control unit1 again Each sub-control unit are connected with a plurality ofelectrodes so it sends out the stimulation pulses according to theinstructions received from the master unit.

It is also possible for several sub-control units to simultaneously sendout stimulation signals to the electrodes because all the sub-controlunit receive the stimulation signals from the master unit. It is alsopossible for the master unit to vary the pulse length of each pulse inthe stimulation signal so that pulse 1 is, for example, 200 microsecondswhile the second pulse is, for example, 175 microseconds and the thirdpulse is, for example, 180 microseconds. It is also possible to changethe voltage level for each pulse in the same way. This would primarilybe used when certain nodes lack the arrangement 513, the allow pulse-out794 function and the ability to locally control the pulse length.

It is also possible to utilize multi-programs in the body-suit thatinclude a mild muscle contraction program and then use a moisturizingand/or conductive cream/gel to be applied locally on the skin wheremuscle contractions take place just before stimulation signals are sentto start the treatment of the muscles/nerves.

A suitable frequency range of the stimulation signal may be in a rangeof 1 Hz to 120 Hz that covers most excitatory and inhibitoryintervention needs. The lower end of the frequency range would be usefulfor testing and palpated or automated intensity adjustments. It is alsoan important feature of the present invention to be able to usedifferent frequencies in different channels for adapting to differentrequirements in individual lesion profiles.

It is also possible to stimulate skin afferents although the size andsensitivity ranges are very broad ranging from fast group II myelinatedto very slow group IV unmyelinated and conduction speed from approx. 1to 70 m/s wherein the speed is proportionally sensitive to theartificial stimuli.

As mentioned above, strong stimulation for inducing muscle contractionscan be limited when using dry electrodes because most spinal cordinjured patients also lose their ability to sweat (lesion effects alsothe autonomous neural system) and then the electrical contact resistancecannot adapt with delivered moisture. It is therefore particularlyimportant that the present invention enables the control and adjustmentsof voltage, current and pulse length etc. to adjust the stimulationsignals to the conditions of the skin and patient.

It has been realized that the stimulation of many locations in the bodysuch as muscles and nerves by using the body suit of the presentinvention increases the release of opioid receptors so that multi-focalstimulation reduces pain in general and could be a method for reducingthe need for patients to take pain killers such as opioid pills.

FIG. 25 is a schematic view of an alternative embodiment of the bodysuit 1200 of the present invention that has large electrodes 1202. Bodysuit 1200 is substantially similar to the body suits shown in FIGS. 4and 18 and operate in the same way. The body suit 1200 is not describedin detail because all the features described in connection with theembodiments shown in FIGS. 4 and 18 also apply to body suit 1200. Theonly difference between body suit 1200 and the embodiments shown inFIGS. 4 and 18 is that body suit 1200 has very large electrodes 1202that are connected to sub-control units 1204. The electrodes 1202 couldbe made so large that they cover substantially all the surfaces on thebody suit 1200. Also, the number of sub-control units 1204 is highercompared to the body suit 100 to enable more electrodes in the suit.Only a portion of the body suit is shown in FIG. 25 and the body suit1200 could be made to cover the entire body as shown in FIG. 4.

It is to be understood that the present invention is not limited to beused in connection with the body suit shown in FIG. 4 and other figures.The body suit 100 is merely an illustrative example. The sub-controlunits and the electrodes could be used in connection with any garment orpiece of fabric. The garment could be separate pieces of fabric thatcontain the electrodes. It is even possible to place the electrodesdirectly on the skin of the patient without a garment or fabric holdingthe electrodes in place. In addition to the upper-body, the arms, pelvisand leg modules, the body suit can also be divided in other ways so thatspecific areas of the body are stimulated. For example, when the patientto be treated has a handicap that makes it difficult to use the bodysuit, smaller pieces of elastic or non-elastic materials, that containelectrodes, may be used so that the material pieces are placed on theparts of the patient's body that need stimulation. Another example iswhen the patient suffers from bed sores, the small pieces of garment orfabric containing the electrodes may be placed on the patient'sbody/skin so that the wound and its circumference can be stimulated. Thesmall pieces of elastic fabric with electrodes are controlled by themaster unit and each small piece is controlled by sub-control units thatin turn control the electrodes in the same way as described above. Thenumber of sub-controls units is determined by the number of electrodesin the small pieces. It is also possible to use full body sized garmentpieces with the same technology so that patients/persons can lie on thelarge garment piece or so that a portion of the patient's body can lieon the garment to stimulate different muscles/nerves without the patienthaving to get into a body suit. The small pieces can be made to includean extra weight so that a good contact with the electrodes is obtainedwhen the electrodes are placed on top of a muscle on the body.

While the present invention has been described in accordance withpreferred compositions and embodiments, it is to be understood thatcertain substitutions and alterations may be made thereto withoutdeparting from the spirit and scope of the following claims.

We claim:
 1. A method for treating a patient, comprising: providing agarment worn by the patient, the garment having a first sub-control unitelectrically connected to a first electrode and a second electrodeplaced at a first muscle or first nerve and a third electrode and fourthelectrode placed at a second muscle or second nerve of the patient, thefirst sub-control unit being electrically connected to a master unit;prior to sending a first stimulation signal to the first sub-controlunit, the master unit sending first data units to instruct the firstsub-control unit to send the first stimulation signal to the firstelectrode; the master unit sending the first stimulation signal to thefirst sub-control unit, the first sub-control unit receiving the firststimulation signal and forwarding the first stimulation signal to thefirst electrode to stimulate the first muscle or first nerve with thefirst stimulation signal; and in a time-gap between the firststimulation signal and a second stimulation signal to the firstsub-control unit, the master unit sending second data units to the firstsub-control unit to instruct the first sub-control unit to send thesecond stimulation signal to the third electrode to stimulate the secondmuscle or second nerve with the second stimulation signal; and themaster unit sending no data units while the first muscle or first nerveis being stimulated by the first stimulation signal and the while thesecond muscle or second nerve is being stimulated by the secondstimulation signal.
 2. The method of claim 1 wherein the method furthercomprises the step of changing a direction of current flowing betweenthe first electrode via the first muscle or first nerve and the secondelectrode.
 3. The method of claim 2 wherein the method further comprisesthe step of intermittently changing a direction of the current.
 4. Themethod of claim 3 wherein the method further comprises the step ofswitching the direction of the current during the first stimulationsignal.
 5. The method of claim 4 wherein the method further comprisesthe step of the master unit sending power, data unit and stimulationsignals to the first sub-control unit in a pair of wires extendingbetween the master unit and the first sub-control unit.
 6. The method ofclaim 1 wherein the method further comprises the step of the master unitsending instructions to the first sub-control unit through a serial databus.
 7. The method of claim 6 wherein the method further comprises thestep of the master unit sending instructions to a second sub-controlunit, the first sub-control unit ignoring the instructions sent to thesecond sub-control unit.